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Clinical Trial Results:
A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate EDP-938 Regimens In Subjects Aged 28 Days to 36 Months Infected with Respiratory Syncytial Virus (RSV)

Summary
EudraCT number	2020-001966-13
Trial protocol	DE PL ES RO
Global end of trial date	19 Aug 2024

Results information
Results version number	v2(current)
This version publication date	02 Aug 2025
First version publication date	06 Mar 2025
Other versions	v1
Version creation reason	New data added to full data set Secondary analysis data added.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

EDP 938-201

ISRCTN number

US NCT number

NCT04816721

WHO universal trial number (UTN)

Sponsor organisation name

Enanta Pharmaceuticals, Inc.

Sponsor organisation address

4 Kingsbury Ave, Watertown, MA, United States, 02472

Public contact

Medical Monitor, Enanta Pharmaceuticals, Inc., +1 6176070800, enquiries@enanta.com

Scientific contact

Medical Monitor, Enanta Pharmaceuticals, Inc., +1 6176070800, enquiries@enanta.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-003609-PIP01-24

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

19 Aug 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

19 Aug 2024

Was the trial ended prematurely?

Main objective of the trial

The main objectives of Part 1 of the study were to evaluate the pharmacokinetics (PK) of EDP-938 and to assess the safety and tolerability of EDP-938. The main objective of Part 2 of the study was to evaluate the antiviral activity of EDP-938.

Protection of trial subjects

The study was conducted in compliance with the protocol, principles of E6 Good Clinical Practice: Consolidated Guidance (ICH-GCP), Declaration of Helsinki, and all applicable local laws and regulations governing clinical studies.

Background therapy

Evidence for comparator

Actual start date of recruitment

26 Apr 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 29

Country: Number of subjects enrolled

Spain: 23

Country: Number of subjects enrolled

Poland: 3

Country: Number of subjects enrolled

Argentina: 8

Country: Number of subjects enrolled

South Africa: 8

Country: Number of subjects enrolled

Taiwan: 8

Country: Number of subjects enrolled

Mexico: 5

Country: Number of subjects enrolled

Israel: 7

Country: Number of subjects enrolled

Brazil: 4

Country: Number of subjects enrolled

Romania: 2

Country: Number of subjects enrolled

Australia: 2

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

A total of 99 participants were enrolled at 78 sites across 15 countries between April 2022 and August 2024.

Screening details

Participants were randomized 2:1 (Part 1) or 4:1 (Part 2) to EDP-938:placebo. One participant was randomized to placebo, but received 7.5 mg/kg EDP-938 in error.

Number of subjects started

Number of subjects completed

Reason: Number of subjects

Miscellaneous: 1

Reason: Number of subjects

Withdrawal by Subject: 2

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Part 1, Group 1: EDP-938

Arm description

Participants aged ≥ 6 months to < 12 months received oral 5 mg/kg doses of EDP-938 once daily (QD) from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 5 mg/kg or 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Experimental

Investigational medicinal product name

EDP-938

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Part 1, Group 2: EDP-938

Arm description

Participants aged ≥ 28 days to < 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Experimental

Investigational medicinal product name

EDP-938

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Part 1, Group 1: Placebo

Arm description

Participants aged ≥ 6 months to ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Placebo matching EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Part 1, Group 2: Placebo

Arm description

Participants aged between ≥ 28 days and < 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Placebo matching EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Part 2, Group 1: EDP-938

Arm description

Participants aged ≥ 6 months to < 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Experimental

Investigational medicinal product name

EDP-938

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Part 2, Group 2: EDP-938

Arm description

Participants aged ≥ 28 days to < 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Experimental

Investigational medicinal product name

EDP-938

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Part 2, Group 1: Placebo

Arm description

Participants aged between ≥ 6 months and ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Placebo matching EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Part 2, Group 2: Placebo

Arm description

Participants aged between ≥ 28 days and < 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Placebo matching EDP-938 was received orally by mouth, nasogastric tube, or orogastric tube.

Number of subjects in period 1 ^[1]	Part 1, Group 1: EDP-938	Part 1, Group 2: EDP-938	Part 1, Group 1: Placebo	Part 1, Group 2: Placebo	Part 2, Group 1: EDP-938	Part 2, Group 2: EDP-938	Part 2, Group 1: Placebo	Part 2, Group 2: Placebo
Started	22	13	11	6	19	15	6	4
Treated With 5 mg/kg EDP-938	14 ^[2]	13	0 ^[3]	0 ^[4]	8 ^[5]	15	0 ^[6]	0 ^[7]
Treated With 7.5 mg/kg EDP-938	9 ^[8]	0 ^[9]	0 ^[10]	0 ^[11]	11 ^[12]	0 ^[13]	0 ^[14]	0 ^[15]
Treated With Placebo	0 ^[16]	0 ^[17]	11	6	0 ^[18]	0 ^[19]	6	4
Completed	22	12	11	4	19	15	6	4
Not completed	0	1	0	2	0	0	0	0
Lost to Follow-up	-	-	-	1	-	-	-	-
Withdrawal by Subject	-	1	-	1	-	-	-	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Baseline period represents those that received treatment.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.
[19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestone N/A for this arm as participants received one of two EDP-938 doses and are represented in different milestones.

Baseline characteristics

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Reporting group title

Overall Study

Reporting group description

Reporting group values	Overall Study	Total
Number of subjects	96	96
Age categorical
Units: Subjects
≥ 28 days to < 3 months	22	22
≥ 3 months to < 6 months	16	16
≥ 6 months to < 12 months	22	22
≥ 12 months to ≤ 36 months	36	36
Gender categorical
Units: Subjects
Female	49	49
Male	47	47
Race
Units: Subjects
American Indian or Alaska Native	0	0
Asian	9	9
Black or African American	15	15
Native Hawaiian or Other Pacific Islander	0	0
White	62	62
Other	6	6
Not Reported	3	3
Unknown	1	1
Ethnicity
Units: Subjects
Hispanic or Latino	38	38
Not Hispanic or Latino	57	57
Not Reported	1	1
Hospitalization Status on Day 1
Units: Subjects
Yes	77	77
No	19	19

End points

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Reporting group title

Part 1, Group 1: EDP-938

Reporting group description

Reporting group title

Part 1, Group 2: EDP-938

Reporting group description

Participants aged ≥ 28 days to < 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 1, Group 1: Placebo

Reporting group description

Participants aged ≥ 6 months to ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 1, Group 2: Placebo

Reporting group description

Participants aged between ≥ 28 days and < 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 2, Group 1: EDP-938

Reporting group description

Reporting group title

Part 2, Group 2: EDP-938

Reporting group description

Participants aged ≥ 28 days to < 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 2, Group 1: Placebo

Reporting group description

Participants aged between ≥ 6 months and ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 2, Group 2: Placebo

Reporting group description

Participants aged between ≥ 28 days and < 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 28 days and < 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 3 months and < 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 6 months and < 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 1: EDP-938

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 1: Placebo

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 2: EDP-938

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 2: Placebo

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Combined EDP-938

Subject analysis set type

Full analysis

Subject analysis set description

Participants in Part 1 and Part 2 who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Combined Placebo

Subject analysis set type

Full analysis

Subject analysis set description

Participants in Part 1 and Part 2 who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 2: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 28 days and < 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 2: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 3 months and < 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 2: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 6 months and < 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Part 2: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Combined EDP-938 5mg/kg (≥ 28 Days to < 3 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 28 days and < 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Combined EDP-938 5mg/kg (≥ 3 Months to < 6 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 3 months and < 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Combined EDP-938 5mg/kg (≥ 6 Months to < 12 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 6 months and < 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Combined EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Subject analysis set title

Combined EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)

Subject analysis set type

Full analysis

Subject analysis set description

Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.

Primary: Part 1: Concentrations of EDP-938 in Plasma

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End point title

Part 1: Concentrations of EDP-938 in Plasma ^[1]

End point description

Plasma concentrations of EDP-938 were assessed at the designated time points. 99999 = Data not available. PK Population: Included all participants in Part 1 who received one full dose of study drug and had samples with quantifiable plasma levels to allow for estimation of PK parameters. Per protocol, data were analyzed per age group and dose received.

End point type

Primary

End point timeframe

3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No additional statistical analysis was pre-specified for this endpoint.

End point values	Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)	Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)	Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)	Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)	Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Number of subjects analysed	9 ^[2]	4 ^[3]	7 ^[4]	7 ^[5]	9 ^[6]
Units: ng/mL
arithmetic mean (standard deviation)
Day 1	1132.222 ( 397.4289 )	1989.500 ( 1331.5646 )	1819.286 ( 809.9508 )	1420.000 ( 604.8140 )	1428.250 ( 817.4801 )
Day 2	368.400 ( 149.8741 )	399.250 ( 423.9515 )	502.350 ( 379.6487 )	249.675 ( 294.5416 )	238.900 ( 239.0287 )
Day 3	448.000 ( 229.1026 )	99999 ( 99999 )	346.000 ( 54.7449 )	97.533 ( 64.9043 )	116.250 ( 43.4871 )
Day 5	528.563 ( 284.6010 )	201.750 ( 98.6623 )	431.429 ( 637.5664 )	252.043 ( 329.2155 )	180.622 ( 158.3268 )

Notes
[2] - Day 1 N = 9 Day 2 N = 7 Day 3 N = 2 Day 5 N = 7
[3] - Day 1 N = 4 Day 2 N = 4 Day 3 N = 0 Day 5 N = 4
[4] - Day 1 N = 7 Day 2 N = 4 Day 3 N = 3 Day 5 N = 7
[5] - Day 1 N = 6 Day 2 N = 4 Day 3 N = 3 Day 5 N = 7
[6] - Day 1 N = 8 Day 2 N = 7 Day 3 N = 2 Day 5 N = 9

No statistical analyses for this end point

Primary: Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

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End point title

Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) ^[7]

End point description

TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs. Safety Population: Included all participants in Part 1 who received any dose (including partial doses) of any study drug. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Primary

End point timeframe

Day 1 to Day 28

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No additional statistical analysis was pre-specified for this endpoint.

End point values	Part 1: EDP-938	Part 1: Placebo
Number of subjects analysed	36	16
Units: participants	14	9

No statistical analyses for this end point

Primary: Part 2: Model-adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples

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End point title

Part 2: Model-adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples

End point description

Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV ribonucleic acid (RNA) viral load and was measured using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Primary

End point timeframe

Baseline and pre-dose on Days 3, 5, 9, and 14

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	34	10
Units: log10 copies/mL
least squares mean (standard error)
Day 3	-1.33 ( 0.297 )	-0.37 ( 0.533 )
Day 5	-3.04 ( 0.354 )	-1.62 ( 0.627 )
Day 9	-3.65 ( 0.381 )	-3.22 ( 0.680 )
Day 14	-4.87 ( 0.388 )	-5.71 ( 0.677 )

Day 3: EDP-938 Versus Placebo

Statistical analysis description

The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.

Comparison groups

Part 2: EDP-938 v Part 2: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1249

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.96

Confidence interval

level

95%

sides

2-sided

lower limit

-2.21

upper limit

0.28

Day 5: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Part 2: EDP-938 v Part 2: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.058

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.41

Confidence interval

level

95%

sides

2-sided

lower limit

-2.88

upper limit

0.05

Day 9: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Part 2: EDP-938 v Part 2: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5877

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-2.02

upper limit

1.16

Day 14: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Part 2: EDP-938 v Part 2: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2932

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

0.84

Confidence interval

level

95%

sides

2-sided

lower limit

-0.76

upper limit

2.43

Primary: Pooled Population: Model-adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

Top of page

End point title

Pooled Population: Model-adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

End point description

Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV RNA viral load and was measured using RT-qPCR from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Primary

End point timeframe

Baseline and pre-dose on Days 3, 5, 9, and 14

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	69	27
Units: log10 copies/mL
least squares mean (standard error)
Day 3	-1.53 ( 0.192 )	-1.36 ( 0.331 )
Day 5	-2.95 ( 0.230 )	-2.62 ( 0.392 )
Day 9	-4.57 ( 0.275 )	-3.87 ( 0.475 )
Day 14	-5.01 ( 0.278 )	-5.35 ( 0.462 )

Day 3: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6574

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.93

upper limit

0.59

Day 5: EDP-938 Versus Placebo

Statistical analysis description

The model includes treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix is imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom.

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4728

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-1.23

upper limit

0.58

Day 9: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2058

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.79

upper limit

0.39

Day 14: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5391

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-0.74

upper limit

1.41

Secondary: Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load

Top of page

End point title

Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14

End point values	Part 1: EDP-938	Part 1: Placebo	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	34	12	29 ^[8]	9
Units: log10 copies/mL*Days
arithmetic mean (standard deviation)
Day 1 through Day 3	17.80 ( 4.522 )	17.26 ( 4.691 )	17.15 ( 4.663 )	16.91 ( 3.266 )
Day 1 through Day 5	25.54 ( 8.301 )	24.55 ( 8.457 )	24.76 ( 7.914 )	26.22 ( 7.069 )
Day 1 through Day 9	36.03 ( 16.229 )	35.20 ( 17.156 )	37.00 ( 13.652 )	40.39 ( 13.371 )
Day 1 through Day 14	42.85 ( 24.990 )	44.16 ( 25.056 )	45.49 ( 21.109 )	42.17 ( 19.864 )

Notes
[8] - Days 1-3 N = 25

No statistical analyses for this end point

Secondary: Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load

Top of page

End point title

Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load

End point description

The RSV RNA viral load was measured using RT-qPCR from nasal swabs. The AUC was calculated using the trapezoid rule. The AUC was calculated based on all available assessments collected on Days 1, 3, 5, 9 and 14 and the actual date/time of each assessment was used for the calculation. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	69	27
Units: log10 copies/mL*Days
least squares mean (standard error)
Day 1 through Day 3	-1.53 ( 0.192 )	-1.36 ( 0.331 )
Day 1 through Day 5	-6.00 ( 0.540 )	-5.33 ( 0.930 )
Day 1 through Day 9	-21.04 ( 1.319 )	-18.32 ( 2.272 )
Day 1 through Day 14	-45.00 ( 2.105 )	-41.36 ( 3.619 )

Day 1 through Day 3: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6574

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.93

upper limit

0.59

Day 1 through Day 5: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5359

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.67

Confidence interval

level

95%

sides

2-sided

lower limit

-2.81

upper limit

1.47

Day 1 through Day 9: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3029

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.73

Confidence interval

level

95%

sides

2-sided

lower limit

-7.95

upper limit

2.5

Day 1 through Day 14: EDP-938 Versus Placebo

Statistical analysis description

Comparison groups

Combined EDP-938 v Combined Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3871

Method

Mixed-effect Model of Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-3.64

Confidence interval

level

95%

sides

2-sided

lower limit

-11.98

upper limit

4.69

Secondary: Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

Top of page

End point title

Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

End point description

Daily change from baseline in RSV shedding in nasal swab samples was defined as the absolute daily change from baseline in RSV RNA viral load and measured using RT-qPCR from nasal swabs. Efficacy Population: Included all participants in Part 1 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Baseline to pre-dose on Days 3, 5, 9, and Day 14

End point values	Part 1: EDP-938	Part 1: Placebo
Number of subjects analysed	34 ^[9]	12 ^[10]
Units: log10 copies/mL
arithmetic mean (standard deviation)
Day 3	-1.68 ( 1.239 )	-2.17 ( 1.948 )
Day 5	-2.91 ( 1.634 )	-3.44 ( 1.585 )
Day 9	-5.34 ( 2.338 )	-4.41 ( 1.897 )
Day 14	-5.11 ( 2.378 )	-5.15 ( 2.118 )

Notes
[9] - Day 5 N = 33 Day 9 N = 32 Day 14 N = 31
[10] - Day 9 N = 11

No statistical analyses for this end point

Secondary: Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)

Top of page

End point title

Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)

End point description

The RSV RNA viral load was measured using RT-qPCR from nasal swabs. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Included only participants with detectable viral load at baseline and non-missing viral load assessment at the respective visit and was used as a denominator in the percentage population.

End point type

Secondary

End point timeframe

Pre-dose on Days 3, 5, 9 and 14

End point values	Part 1: EDP-938	Part 1: Placebo	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	34 ^[11]	12 ^[12]	28 ^[13]	9 ^[14]
Units: percentage of participants
number (confidence interval 95%)
Day 3	0 (0.00 to 10.28)	8.3 (0.21 to 38.48)	3.6 (0.09 to 18.35)	0 (0.00 to 33.63)
Day 5	12.1 (3.40 to 28.20)	16.7 (2.09 to 48.41)	22.2 (8.62 to 42.26)	0 (0.00 to 33.63)
Day 9	62.5 (43.69 to 78.90)	36.4 (10.93 to 69.21)	28.0 (12.07 to 49.39)	25.0 (3.19 to 65.09)
Day 14	61.3 (42.19 to 78.15)	58.3 (27.67 to 84.83)	63.0 (42.37 to 80.60)	88.9 (51.75 to 99.72)

Notes
[11] - Day 5 N = 33 Day 9 N = 32 Day 14 N = 31
[12] - Day 9 N = 11
[13] - Day 5 N = 27 Day 9 N = 25 Day 14 N = 27
[14] - Day 9 N = 8

No statistical analyses for this end point

Secondary: Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD

Top of page

End point title

Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD

End point description

End point type

Secondary

End point timeframe

Pre-dose on Days 3, 5, 9 and 14

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	62 ^[15]	21 ^[16]
Units: percentage of participants
number (confidence interval 95%)
Day 3	1.6 (0.04 to 8.66)	4.8 (0.12 to 23.82)
Day 5	16.7 (8.29 to 28.52)	9.5 (1.17 to 30.38)
Day 9	47.4 (33.98 to 61.03)	31.6 (12.58 to 56.55)
Day 14	62.1 (48.37 to 74.49)	71.4 (47.82 to 88.72)

Notes
[15] - Day 5 N = 60 Day 9 N = 57 Day 14 N = 58
[16] - Day 9 N = 19

No statistical analyses for this end point

Secondary: Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable

Top of page

End point title

Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable

End point description

Time to RSV RNA viral load being undetectable was calculated as: first date of RSV RNA viral load target not detected (TND) after which no further samples had detectable RSV RNA viral load - date of first dose. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 1: EDP-938	Part 1: Placebo	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	34	14	29	9
Units: days
arithmetic mean (standard deviation)	10.59 ( 3.661 )	12.33 ( 3.018 )	12.46 ( 3.235 )	12.19 ( 3.040 )

No statistical analyses for this end point

Secondary: Pooled Population: Time to RSV RNA Viral Load Being Undetectable

Top of page

End point title

Pooled Population: Time to RSV RNA Viral Load Being Undetectable

End point description

Time to RSV RNA viral load being undetectable was calculated as: first date of RSV RNA viral load TND after which no further samples had detectable RSV RNA viral load - date of first dose. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	63	23
Units: days
arithmetic mean (standard deviation)	11.45 ( 3.570 )	12.27 ( 2.958 )

No statistical analyses for this end point

Secondary: Part 2: Number of Participants Who Experienced a TEAE

Top of page

End point title

Part 2: Number of Participants Who Experienced a TEAE

End point description

TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs. Safety Population: Included all participants in Part 2 who received any dose (including partial doses) of any study drug. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	34	10
Units: participants	14	4

No statistical analyses for this end point

Secondary: Pooled Population: Number of Participants Who Experienced a TEAE

Top of page

End point title

Pooled Population: Number of Participants Who Experienced a TEAE

End point description

TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs. Safety Population: Included all participants who received any dose (including partial doses) of any study drug. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	70	26
Units: participants	28	13

No statistical analyses for this end point

Secondary: Part 2: Concentrations of EDP-938 in Plasma

Top of page

End point title

Part 2: Concentrations of EDP-938 in Plasma

End point description

Plasma concentrations of EDP-938 were assessed at the designated time points. Values of "99999" indicate N/A. PK Population: Included all participants in Part 2 who received one full dose of study drug and had samples with quantifiable plasma levels to allow for estimation of PK parameters. Per protocol, data were analyzed per age group and dose received.

End point type

Secondary

End point timeframe

3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5

End point values	Part 2: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)	Part 2: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)	Part 2: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)	Part 2: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Number of subjects analysed	7 ^[17]	8 ^[18]	7 ^[19]	9 ^[20]
Units: ng/mL
arithmetic mean (standard deviation)
Day 1	1116.286 ( 217.9983 )	1169.903 ( 802.0744 )	1551.429 ( 363.8419 )	1368.111 ( 469.7815 )
Day 2	585.400 ( 119.6089 )	273.500 ( 150.4616 )	140.783 ( 73.3099 )	200.700 ( 134.3896 )
Day 3	194.000 ( 99999 )	926.000 ( 57.9828 )	112.000 ( 99999 )	115.967 ( 84.9347 )
Day 5	516.333 ( 247.6697 )	519.714 ( 436.8130 )	69.110 ( 40.4604 )	153.450 ( 102.4372 )

Notes
[17] - Day 2 N = 5 Day 3 N = 1 Day 5 N = 6
[18] - Day 2 N = 6 Day 3 N = 2 Day 5 N = 7
[19] - Day 2 N = 6 Day 3 N = 1
[20] - Day 2 N = 6 Day 3 N = 3 Day 5 N = 8

No statistical analyses for this end point

Secondary: Pooled Population: Concentrations of EDP-938 in Plasma

Top of page

End point title

Pooled Population: Concentrations of EDP-938 in Plasma

End point description

Plasma concentrations of EDP-938 were assessed at the designated time points. PK Population: Included all participants who received one full dose of study drug and had samples with quantifiable plasma levels to allow for estimation of PK parameters. Per protocol, data were analyzed per age group and dose received.

End point type

Secondary

End point timeframe

3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5

End point values	Combined EDP-938 5mg/kg (≥ 28 Days to < 3 Months)	Combined EDP-938 5mg/kg (≥ 3 Months to < 6 Months)	Combined EDP-938 5mg/kg (≥ 6 Months to < 12 Months)	Combined EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)	Combined EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Number of subjects analysed	16 ^[21]	12 ^[22]	14 ^[23]	7 ^[24]	18 ^[25]
Units: ng/mL
arithmetic mean (standard deviation)
Day 1	1125.250 ( 321.4278 )	1443.102 ( 1027.5197 )	1685.357 ( 619.0267 )	1420.000 ( 604.8140 )	1396.412 ( 635.3537 )
Day 2	458.817 ( 173.0322 )	323.800 ( 276.9576 )	285.410 ( 293.0727 )	249.675 ( 294.5416 )	221.269 ( 191.0117 )
Day 3	363.333 ( 218.5162 )	926.000 ( 57.9828 )	287.500 ( 125.2478 )	97.533 ( 64.9043 )	116.080 ( 63.8730 )
Day 5	522.918 ( 257.0945 )	404.091 ( 378.3365 )	250.269 ( 472.9799 )	252.043 ( 329.2155 )	167.835 ( 131.6054 )

Notes
[21] - Day 2 N = 12 Day 3 N = 3 Day 5 N = 13
[22] - Day 2 N = 10 Day 3 N = 2 Day 5 N = 11
[23] - Day 2 N = 10 Day 3 N = 4
[24] - Day 1 N = 6 Day 2 N = 4 Day 3 N = 3
[25] - Day 1 N = 17 Day 2 N = 13 Day 3 N = 5 Day 5 N = 17

No statistical analyses for this end point

Secondary: Part 2: Time to First Hospital Discharge for Hospitalized Participants

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End point title

Part 2: Time to First Hospital Discharge for Hospitalized Participants

End point description

Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Only participants who were hospitalized at randomization were included. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	29	7
Units: days
arithmetic mean (standard deviation)	3.93 ( 1.870 )	4.00 ( 3.367 )

No statistical analyses for this end point

Secondary: Pooled Population: Time to First Hospital Discharge for Hospitalized Participants

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End point title

Pooled Population: Time to First Hospital Discharge for Hospitalized Participants

End point description

Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Only participants who were hospitalized at randomization were included. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	56	21
Units: days
arithmetic mean (standard deviation)	3.71 ( 2.006 )	3.57 ( 2.959 )

No statistical analyses for this end point

Secondary: Part 2: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

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End point title

Part 2: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

End point description

For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. As there were no participants in Part 2 in both arms who were hospitalized at randomization who were not receiving oxygen at the time they received the first dose of study drug, no data were collected for this outcome measure.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	0 ^[26]	0 ^[27]
Units: days
arithmetic mean (standard deviation)	( )	( )

Notes
[26] - No data were collected for this outcome measure.
[27] - No data were collected for this outcome measure.

No statistical analyses for this end point

Secondary: Pooled Population: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

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End point title

Pooled Population: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

End point description

For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days. Values of "99999" indicate N/A. Efficacy Population. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only hospitalized participants who were not receiving oxygen at the time they received the first dose of study drug were included. In the Placebo arm, there were no hospitalized participants who were not receiving oxygen at the time they received the first dose of study drug.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	1	0 ^[28]
Units: days
arithmetic mean (standard deviation)	0.51 ( 99999 )	( )

Notes
[28] - No hospitalized participants who were not receiving oxygen at the time they received study drug.

No statistical analyses for this end point

Secondary: Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

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End point title

Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

End point description

The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for oxygen supplementation or new increase in oxygen requirements after the first dose of study drug, based on the response of "yes" to the "Is this an increase of oxygen supplementation compared to previous use?" question on the Oxygen Supplementation case report form (CRF). The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only participants who were hospitalized at randomization and/or during the study were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	29	7
Units: percentage of participants
number (confidence interval 95%)	24.1 (10.30 to 43.54)	28.6 (3.67 to 70.96)

No statistical analyses for this end point

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

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End point title

Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

End point description

The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for oxygen supplementation or new increase in oxygen requirements after the first dose of study drug, based on the response of "yes" to the "Is this an increase of oxygen supplementation compared to previous use?" question on the Oxygen Supplementation CRF. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only participants who were hospitalized at randomization and/or during the study were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	56	21
Units: percentage of participants
number (confidence interval 95%)	25.0 (14.39 to 38.37)	19.0 (5.45 to 41.91)

No statistical analyses for this end point

Secondary: Part 2: Time to Mechanical Ventilation for Hospitalized Participants

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End point title

Part 2: Time to Mechanical Ventilation for Hospitalized Participants

End point description

Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. As only participants who were hospitalized at baseline and experienced mechanical ventilation were included, no data were collected for this outcome measure.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	0 ^[29]	0 ^[30]
Units: days
arithmetic mean (standard deviation)	( )	( )

Notes
[29] - No data were collected for this outcome measure.
[30] - No data were collected for this outcome measure.

No statistical analyses for this end point

Secondary: Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants

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End point title

Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants

End point description

Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. As only participants who were hospitalized at baseline and experienced mechanical ventilation after their first dose of study drug were included, no data were collected for this outcome measure.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	0 ^[31]	0 ^[32]
Units: days
arithmetic mean (standard deviation)	( )	( )

Notes
[31] - No data were collected for this outcome measure.
[32] - No data were collected for this outcome measure.

No statistical analyses for this end point

Secondary: Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

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End point title

Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

End point description

The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only hospitalized participants who were not on mechanical ventilation prior to the first dose of study drug were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	29	7
Units: percentage of participants
number (confidence interval 95%)	0 (0.00 to 11.94)	0 (0.00 to 40.96)

No statistical analyses for this end point

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

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End point title

Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

End point description

The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only hospitalized participants who were not on mechanical ventilation prior to the first dose of study drug were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	56	21
Units: percentage of participants
number (confidence interval 95%)	0 (0.00 to 6.38)	0 (0.00 to 16.11)

No statistical analyses for this end point

Secondary: Part 2: Percentage of Hospitalized Participants Who Died During the Study

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End point title

Part 2: Percentage of Hospitalized Participants Who Died During the Study

End point description

The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only participants who were hospitalized at randomization and/or during the study were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	29	7
Units: percentage of participants
number (confidence interval 95%)	0 (0.00 to 11.94)	0 (0.00 to 40.96)

No statistical analyses for this end point

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Died During the Study

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End point title

Pooled Population: Percentage of Hospitalized Participants Who Died During the Study

End point description

The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only participants who were hospitalized at randomization and/or during the study were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	56	21
Units: percentage of participants
number (confidence interval 95%)	0 (0.00 to 6.38)	0 (0.00 to 16.11)

No statistical analyses for this end point

Secondary: Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

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End point title

Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

End point description

Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. As only participants who were not hospitalized at randomization but subsequently hospitalized were included, no data were collected for this outcome measure.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	0 ^[33]	0 ^[34]
Units: days
arithmetic mean (standard deviation)	( )	( )

Notes
[33] - No data were collected for this outcome measure.
[34] - No data were collected for this outcome measure.

No statistical analyses for this end point

Secondary: Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

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End point title

Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

End point description

Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. As only participants who were not hospitalized at randomization but subsequently hospitalized were included, no data were collected for this outcome measure.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	0 ^[35]	0 ^[36]
Units: days
arithmetic mean (standard deviation)	( )	( )

Notes
[35] - No data were collected for this outcome measure.
[36] - No data were collected for this outcome measure.

No statistical analyses for this end point

Secondary: Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

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End point title

Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

End point description

Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only participants who were not hospitalized at randomization were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	5	3
Units: percentage of participants
number (confidence interval 95%)	0 (0.00 to 52.18)	0 (0.00 to 70.76)

No statistical analyses for this end point

Secondary: Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

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End point title

Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

End point description

Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only participants who were not hospitalized at randomization were included.

End point type

Secondary

End point timeframe

Day 1 to Day 28

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	13	6
Units: percentage of participants
number (confidence interval 95%)	0 (0.00 to 24.71)	0 (0.00 to 45.93)

No statistical analyses for this end point

Secondary: Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

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End point title

Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

End point description

Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver RSV Foundation (ReSVinet) score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14. During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease. Efficacy Population. Only participants who were not hospitalized were included.

End point type

Secondary

End point timeframe

Day 1 to Day 14

End point values	Part 2: EDP-938	Part 2: Placebo
Number of subjects analysed	3	2
Units: days
arithmetic mean (standard deviation)	2.60 ( 1.686 )	1.49 ( 0.702 )

No statistical analyses for this end point

Secondary: Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

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End point title

Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

End point description

Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver ReSVinet score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14. During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease. Efficacy Population. Only participants who were not hospitalized were included.

End point type

Secondary

End point timeframe

Day 1 to Day 14

End point values	Combined EDP-938	Combined Placebo
Number of subjects analysed	8	5
Units: days
arithmetic mean (standard deviation)	2.42 ( 1.163 )	4.20 ( 5.552 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to Day 28

Adverse event reporting additional description

The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

Part 1: EDP-938

Reporting group description

Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 2: EDP-938

Reporting group description

Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 2: Placebo

Reporting group description

Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Reporting group title

Part 1: Placebo

Reporting group description

Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

Serious adverse events	Part 1: EDP-938	Part 2: EDP-938	Part 2: Placebo	Part 1: Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 36 (0.00%)	1 / 34 (2.94%)	0 / 10 (0.00%)	2 / 16 (12.50%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchiolitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 36 (0.00%)	1 / 34 (2.94%)	0 / 10 (0.00%)	0 / 16 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Part 1: EDP-938	Part 2: EDP-938	Part 2: Placebo	Part 1: Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	7 / 36 (19.44%)	9 / 34 (26.47%)	4 / 10 (40.00%)	7 / 16 (43.75%)
Investigations
Myocardial necrosis marker increased
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	1 / 10 (10.00%)	0 / 16 (0.00%)
occurrences all number	0	0	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	1 / 10 (10.00%)	0 / 16 (0.00%)
occurrences all number	0	0	1	0
Thrombocytosis
subjects affected / exposed	0 / 36 (0.00%)	2 / 34 (5.88%)	0 / 10 (0.00%)	0 / 16 (0.00%)
occurrences all number	0	2	0	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 36 (2.78%)	0 / 34 (0.00%)	1 / 10 (10.00%)	0 / 16 (0.00%)
occurrences all number	1	0	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	4 / 36 (11.11%)	3 / 34 (8.82%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	4	3	0	1
Vomiting
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Nasal congestion
subjects affected / exposed	0 / 36 (0.00%)	1 / 34 (2.94%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	1	0	1
Skin and subcutaneous tissue disorders
Dermatitis diaper
subjects affected / exposed	1 / 36 (2.78%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	1	0	0	1
Eczema
subjects affected / exposed	1 / 36 (2.78%)	1 / 34 (2.94%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	1	1	0	1
Papule
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0	0	1
Rash
subjects affected / exposed	1 / 36 (2.78%)	2 / 34 (5.88%)	1 / 10 (10.00%)	0 / 16 (0.00%)
occurrences all number	1	2	1	0
Infections and infestations
Acarodermatitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0	0	1
Nasopharyngitis
subjects affected / exposed	0 / 36 (0.00%)	1 / 34 (2.94%)	1 / 10 (10.00%)	1 / 16 (6.25%)
occurrences all number	0	1	1	1
Otitis media acute
subjects affected / exposed	1 / 36 (2.78%)	1 / 34 (2.94%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	1	1	0	1
Pneumonia bacterial
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0	0	1
Respiratory tract infection
subjects affected / exposed	0 / 36 (0.00%)	0 / 34 (0.00%)	0 / 10 (0.00%)	1 / 16 (6.25%)
occurrences all number	0	0	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

13 Aug 2020

Protocol Version 2.0 (global amendment)

01 Jun 2021

Protocol Version 4.0 (global amendment)

13 Sep 2021

Protocol Version 6.0 (global amendment)

28 Feb 2022

Protocol Version 8.0 (global amendment)

23 Aug 2022

Protocol Version 10.0 (global amendment)

03 Oct 2022

Protocol Version 11.0 (global amendment)

03 Jan 2023

Protocol Version 13.0 (global amendment)

22 Sep 2023

Protocol Version 15.0 (global amendment; submitted to the United States Food and Drug Administration only)

04 Dec 2023

Protocol Version 16.0 (global amendment)

09 Jul 2024

Protocol Version 18.0 (global amendment)

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate EDP-938 Regimens In Subjects Aged 28 Days to 36 Months Infected with Respiratory Syncytial Virus (RSV)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Part 1: Concentrations of EDP-938 in Plasma

Primary: Part 1: Concentrations of EDP-938 in Plasma

Primary: Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

Primary: Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

Primary: Part 2: Model-adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples

Primary: Part 2: Model-adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples

Primary: Pooled Population: Model-adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

Primary: Pooled Population: Model-adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

Secondary: Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load

Secondary: Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load

Secondary: Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load

Secondary: Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load

Secondary: Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

Secondary: Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

Secondary: Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)

Secondary: Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)

Secondary: Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD

Secondary: Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD

Secondary: Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable

Secondary: Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable

Secondary: Pooled Population: Time to RSV RNA Viral Load Being Undetectable

Secondary: Pooled Population: Time to RSV RNA Viral Load Being Undetectable

Secondary: Part 2: Number of Participants Who Experienced a TEAE

Secondary: Part 2: Number of Participants Who Experienced a TEAE

Secondary: Pooled Population: Number of Participants Who Experienced a TEAE

Secondary: Pooled Population: Number of Participants Who Experienced a TEAE

Secondary: Part 2: Concentrations of EDP-938 in Plasma

Secondary: Part 2: Concentrations of EDP-938 in Plasma

Secondary: Pooled Population: Concentrations of EDP-938 in Plasma

Secondary: Pooled Population: Concentrations of EDP-938 in Plasma

Secondary: Part 2: Time to First Hospital Discharge for Hospitalized Participants

Secondary: Part 2: Time to First Hospital Discharge for Hospitalized Participants

Secondary: Pooled Population: Time to First Hospital Discharge for Hospitalized Participants

Secondary: Pooled Population: Time to First Hospital Discharge for Hospitalized Participants

Secondary: Part 2: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

Secondary: Part 2: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

Secondary: Pooled Population: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

Secondary: Pooled Population: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug

Secondary: Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

Secondary: Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug

Secondary: Part 2: Time to Mechanical Ventilation for Hospitalized Participants

Secondary: Part 2: Time to Mechanical Ventilation for Hospitalized Participants

Secondary: Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants

Secondary: Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants

Secondary: Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

Secondary: Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation

Secondary: Part 2: Percentage of Hospitalized Participants Who Died During the Study

Secondary: Part 2: Percentage of Hospitalized Participants Who Died During the Study

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Died During the Study

Secondary: Pooled Population: Percentage of Hospitalized Participants Who Died During the Study

Secondary: Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

Secondary: Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

Secondary: Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

Secondary: Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized

Secondary: Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

Secondary: Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

Secondary: Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

Secondary: Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died

Secondary: Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

Secondary: Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

Secondary: Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

Secondary: Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Clinical Trial Results:
A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate EDP-938 Regimens In Subjects Aged 28 Days to 36 Months Infected with Respiratory Syncytial Virus (RSV)