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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
    		 v1(current)
    This version publication date
    06 Mar 2025
    First version publication date
    06 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EDP 938-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04816721
    WHO universal trial number (UTN)
    		 -
    Sponsors
    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
    Paediatric regulatory details
    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?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    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
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    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
    99
    EEA total number of subjects
    28
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    87
    Children (2-11 years)
    12
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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

    Pre-assignment
    Screening details
    		 Out of the 99 participants that were enrolled, 52 participants received either EDP-938 or placebo in Part 1 and 44 participants received either EDP-938 or placebo in Part 2.

    Period 1
    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: EDP-938
    Arm description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received a lower or higher dose of EDP-938 once daily (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.

    Arm title
    		 Part 1: Placebo
    Arm description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received 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.

    Arm title
    		 Part 2: EDP-938
    Arm description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received a lower or higher dose 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.

    Arm title
    		 Part 2: Placebo
    Arm description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received placebo matching EDP-938 QD on 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
    		Part 1: EDP-938 Part 1: Placebo Part 2: EDP-938 Part 2: Placebo
    Started
    36
    17
    36
    10
    Treated
    35
    17
    34
    10
    Completed
    34
    15
    34
    10
    Not completed
    2
    2
    2
    0
         Consent withdrawn by subject
    2
    1
    1
    -
         Miscellaneous
    -
    -
    1
    -
         Lost to follow-up
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: EDP-938
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received a lower or higher dose of EDP-938 once daily (QD) from Day 1 to Day 5 of the study.

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

    Reporting group title
    Part 2: EDP-938
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received a lower or higher dose of EDP-938 QD from Day 1 to Day 5 of the study.

    Reporting group title
    Part 2: Placebo
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received placebo matching EDP-938 QD on Day 1 to Day 5 of the study.

    Reporting group values
    		 Part 1: EDP-938 Part 1: Placebo Part 2: EDP-938 Part 2: Placebo Total
    Number of subjects
    		 36 17 36 10 99
    Age categorical
    Units: Subjects
        ≥ 28 days to < 6 months
    		 14 6 16 4 40
        ≥ 6 months to ≤ 36 months
    		 22 11 20 6 59
    Gender categorical
    Units: Subjects
        Female
    		 17 9 19 6 51
        Male
    		 19 8 17 4 48
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 4 0 4 1 9
        Black or African American
    		 4 7 5 0 16
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        White
    		 28 6 24 6 64
        Other
    		 0 2 2 2 6
        Not Reported
    		 0 2 0 1 3
        Unknown
    		 0 0 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 14 6 12 6 38
        Not Hispanic or Latino
    		 22 11 23 4 60
        Not Reported
    		 0 0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Part 1: EDP-938
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received a lower or higher dose of EDP-938 once daily (QD) from Day 1 to Day 5 of the study.

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

    Reporting group title
    Part 2: EDP-938
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received a lower or higher dose of EDP-938 QD from Day 1 to Day 5 of the study.

    Reporting group title
    Part 2: Placebo
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received placebo matching EDP-938 QD on Day 1 to Day 5 of the study.

    Subject analysis set title
    Part 1: Lower-dose EDP-938 (≥ 28 days to < 3 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received a lower dose of EDP-938 QD from Day 1 to Day 5 of the study.

    Subject analysis set title
    Part 1: Lower-dose EDP-938 (≥ 3 months to < 6 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received a lower dose of EDP-938 QD from Day 1 to Day 5 of the study.

    Subject analysis set title
    Part 1: Lower-dose EDP-938 (≥ 6 months to < 12 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received a lower dose of EDP-938 QD from Day 1 to Day 5 of the study.

    Subject analysis set title
    Part 1: Lower-dose EDP-938 (≥ 12 months to ≤ 36 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received a lower dose of EDP-938 QD from Day 1 to Day 5 of the study.

    Subject analysis set title
    Part 1: Higher-dose EDP-938 (≥ 12 months to ≤ 36 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received a higher dose of 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 from Part 1 and Part 2 who received a lower or higher dose of EDP-938 QD from Day 1 to Day 5 of the study were pooled for analysis.

    Subject analysis set title
    Combined Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants from Part 1 and Part 2 who received placebo matching EDP-938 QD from Day 1 to Day 5 of the study were pooled for analysis.

    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 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 comparative statistical analyses were planned.
    End point values
    		 Part 1: Lower-dose EDP-938 (≥ 28 days to < 3 months) Part 1: Lower-dose EDP-938 (≥ 3 months to < 6 months) Part 1: Lower-dose EDP-938 (≥ 6 months to < 12 months) Part 1: Lower-dose EDP-938 (≥ 12 months to ≤ 36 months) Part 1: Higher-dose EDP-938 (≥ 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] [8]
    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 Section 4.1 of the statistical analysis plan (SAP), analyses were planned to be grouped by treatment, rather than by specific 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 comparative statistical analyses were planned.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: 'Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)' was a primary endpoint for Part 1 only.
    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: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

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    End point title
    		 Part 2: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples [9] [10]
    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. Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
    End point type
    Primary
    End point timeframe
    Baseline and Days 3, 5, 9, and 14
    Notes
    [9] - 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 comparative statistical analyses were planned.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: 'Daily Change From Baseline in RSV Shedding in Nasal Swab Samples' was a primary endpoint for Part 2 only.
    End point values
    		 Part 2: EDP-938 Part 2: Placebo
    Number of subjects analysed
    28 [11]
    9 [12]
    Units: log10 copies/mL
    arithmetic mean (standard deviation)
        Day 3
    -1.42 ( 1.437 )
    -0.10 ( 1.875 )
        Day 5
    -3.12 ( 2.007 )
    -1.36 ( 1.680 )
        Day 9
    -3.76 ( 1.793 )
    -2.77 ( 2.378 )
        Day 14
    -4.93 ( 2.485 )
    -5.44 ( 1.314 )
    Notes
    [11] - Day 3 N = 28 Day 5 N = 27 Day 9 N = 25 Day 14 N = 27
    [12] - Day 3 N = 9 Day 5 N = 9 Day 9 N = 8 Day 14 N = 9
    No statistical analyses for this end point

    Primary: Pooled Population: Percent Daily Change From Baseline in RSV Shedding in Nasal Swab Samples

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    End point title
    		 Pooled Population: Percent 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 daily change from baseline in RSV RNA viral load and 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 Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
    End point type
    Primary
    End point timeframe
    Baseline and Days 3, 5, 9, 14
    End point values
    		 Combined EDP-938 Combined Placebo
    Number of subjects analysed
    62 [13]
    21 [14]
    Units: log10 copies/mL
    arithmetic mean (standard deviation)
        Day 3
    -1.56 ( 1.327 )
    -1.29 ( 2.143 )
        Day 5
    -3.01 ( 1.798 )
    -2.55 ( 1.906 )
        Day 9
    -4.65 ( 2.244 )
    -3.72 ( 2.212 )
        Day 14
    -5.02 ( 2.408 )
    -5.27 ( 1.783 )
    Notes
    [13] - Day 3 N = 62 Day 5 N = 60 Day 9 N = 57 Day 14 N = 58
    [14] - Day 3 N = 21 Day 5 N = 21 Day 9 N = 19 Day 14 N = 21
    Statistical analysis title
    		 Day 3: 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
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6574
    Method
    		 Mixed-effect model for 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
    Statistical analysis title
    		 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
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4728
    Method
    		 Mixed-effect model for 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
    Statistical analysis title
    		 Day 9: 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
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2058
    Method
    		 Mixed-effect model for 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
    Statistical analysis title
    		 Day 14: 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
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5391
    Method
    		 Mixed-effect model for 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

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 28
    Adverse event reporting additional description
    Safety Population: 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 used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Part 1: EDP-938
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received a lower or higher dose of EDP-938 once daily (QD) from Day 1 to Day 5 of the study.

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and hospitalized participants aged between ≥ 28 days and < 6 months received placebo matching EDP-938 QD from Day 1 to Day 5 of the study.

    Reporting group title
    Part 2: EDP-938
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received a lower or higher dose of EDP-938 QD from Day 1 to Day 5 of the study.

    Reporting group title
    Part 2: Placebo
    Reporting group description
    		 Hospitalized and non-hospitalized participants aged between ≥ 6 months and ≤ 36 months, and between ≥ 28 days and < 6 months received placebo matching EDP-938 QD on Day 1 to Day 5 of the study.

    Serious adverse events
    		 Part 1: EDP-938 Part 1: Placebo Part 2: EDP-938 Part 2: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 16 (12.50%)
    1 / 34 (2.94%)
    0 / 10 (0.00%)
         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%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (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
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (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
    Pneumonia
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 16 (0.00%)
    1 / 34 (2.94%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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 1: Placebo Part 2: EDP-938 Part 2: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 36 (19.44%)
    7 / 16 (43.75%)
    9 / 34 (26.47%)
    4 / 10 (40.00%)
    Investigations
    Myocardial necrosis marker increased
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 16 (0.00%)
    0 / 34 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 16 (0.00%)
    0 / 34 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 16 (0.00%)
    2 / 34 (5.88%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 16 (0.00%)
    0 / 34 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 36 (11.11%)
    1 / 16 (6.25%)
    3 / 34 (8.82%)
    0 / 10 (0.00%)
         occurrences all number
    4
    1
    3
    0
    Vomiting
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    1 / 34 (2.94%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 16 (6.25%)
    1 / 34 (2.94%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Papule
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 16 (0.00%)
    2 / 34 (5.88%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    2
    1
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    1 / 34 (2.94%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    1
    Otitis media acute
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 16 (6.25%)
    1 / 34 (2.94%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 16 (6.25%)
    0 / 34 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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)

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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