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    Clinical Trial Results:
    A Phase 2a open label, non-comparative, single dose escalation study to evaluate the dynamics of viral clearance, pharmacokinetics and tolerability of ensovibep in patients with symptomatic COVID-19 disease

    Summary
    EudraCT number
    		 2021-000365-33
    Trial protocol
    		 NL  
    Global end of trial date
    20 Aug 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Dec 2022
    First version publication date
    13 Oct 2022
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Online reference to be added

    Trial information

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    Trial identification
    Sponsor protocol code
    MP0420-CP204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04834856
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Molecular Partners AG
    Sponsor organisation address
    Wagistrasse 14, Schlieren, Switzerland, 8952
    Public contact
    Medical Director, Molecular Partners AG, info@molecularpartners.com
    Scientific contact
    Medical Director, Molecular Partners AG, info@molecularpartners.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    (1) )To characterize the dynamics of viral clearance (incl. viral cultures, qPCR) following ensovibep administration. (2) To evaluate the serum pharmacokinetics of single, i.v. doses of ensovibep in patients with symptomatic COVID-19 disease.
    Protection of trial subjects
    This study was conducted in accordance with the Note for Guidance on Good Clinical Practice (GCP) International Council for Harmonisation (ICH) Harmonised Tripartite Guideline E6 (R1)/Integrated Addendum E6 (R2); US Food and Drug Administration (FDA) Code of Federal Regulations (CFR) (Title 21 Parts 50, 56, 312), requirements for the conduct of clinical studies as provided in the EU Directive 2001/20/EC, the general guidelines indicated in the Declaration of Helsinki; and all applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 1 research center in the Netherlands from 01Apr2021 to 21May2021. The first 6 participants who were enrolled were assigned to Arm 1. After assessment by the data review committee, the next 6 participants who were enrolled were assigned to Arm 2.

    Pre-assignment
    Screening details
    		 14 patients were screened. There were 2 screen failures (Reasons: negative rapid antigen test at day of dosing and prior anti-SARS-COV-2 vaccination).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ensovibep 225 mg
    Arm description
    		 Single flat dose of 225 mg ensovibep i.v.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ensovibep
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    225 mg single flat dose administered as i.v. infusion.

    Arm title
    		 Ensovibep 600 mg
    Arm description
    		 Single flat dose of 600 mg ensovibep i.v.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ensovibep
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    600 mg single flat dose administered as i.v. infusion.

    Number of subjects in period 1
    		Ensovibep 225 mg Ensovibep 600 mg
    Started
    6
    6
    Completed
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ensovibep 225 mg
    Reporting group description
    		 Single flat dose of 225 mg ensovibep i.v.

    Reporting group title
    Ensovibep 600 mg
    Reporting group description
    		 Single flat dose of 600 mg ensovibep i.v.

    Reporting group values
    		 Ensovibep 225 mg Ensovibep 600 mg Total
    Number of subjects
    		 6 6 12
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.0 ± 2.1 26.8 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 4
        Male
    		 4 4 8
    Race
    Units: Subjects
        Multiple
    		 0 1 1
        White
    		 6 5 11

    End points

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    End points reporting groups
    Reporting group title
    Ensovibep 225 mg
    Reporting group description
    		 Single flat dose of 225 mg ensovibep i.v.

    Reporting group title
    Ensovibep 600 mg
    Reporting group description
    		 Single flat dose of 600 mg ensovibep i.v.

    Subject analysis set title
    ensovibep 225 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    one time administration of ensovibep at day 1 -

    Subject analysis set title
    ensovibep 600mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    one time administration of ensovibep 600mg at Day 1

    Primary: Changes from baseline to each time point of measurement in viral load (quantitative PCR) as per assessment schedule

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    End point title
    		 Changes from baseline to each time point of measurement in viral load (quantitative PCR) as per assessment schedule [1]
    End point description
    End point type
    Primary
    End point timeframe
    change from baseline (mean) at day 8
    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: Descriptive statistics, no statistical hypothesis verified.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    -3.602 ± 0.9418
    -3.420 ± 1.8205
    Attachments
    		 Untitled (Filename: 420_204_CFB viral load.pdf)
    No statistical analyses for this end point

    Primary: Number of patients with negative PCR

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    End point title
    		 Number of patients with negative PCR [2]
    End point description
    End point type
    Primary
    End point timeframe
    at day 8
    Notes
    [2] - 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: Descriptive statistics, no statistical hypothesis verified.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: number of patients
    0
    0
    No statistical analyses for this end point

    Primary: AUCinf

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    End point title
    		 AUCinf [3]
    End point description
    End point type
    Primary
    End point timeframe
    28 days
    Notes
    [3] - 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: Descriptive statistics, no statistical hypothesis verified.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    5 [4]
    6
    Units: h*ug/mL
        geometric mean (standard deviation)
    37170 ± 18.1
    100068 ± 37.9
    Attachments
    		 Untitled (Filename: summary PK.pdf)
    Notes
    [4] - 1 patient was not evaluable for this parameter
    No statistical analyses for this end point

    Primary: Clearance (CL)

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    End point title
    		 Clearance (CL) [5]
    End point description
    End point type
    Primary
    End point timeframe
    28 days
    Notes
    [5] - 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: Descriptive statistics, no statistical hypothesis verified.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    5 [6]
    6
    Units: mL/h
        arithmetic mean (standard deviation)
    6.13 ± 1.02
    6.39 ± 2.81
    Notes
    [6] - 1 patient was not evaluable for this parameter
    No statistical analyses for this end point

    Primary: C max

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    End point title
    		 C max [7]
    End point description
    End point type
    Primary
    End point timeframe
    28 days
    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: Descriptive statistics, no statistical hypothesis verified.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: ug/mL
        geometric mean (geometric coefficient of variation)
    88.8 ± 20.3
    233 ± 19.3
    No statistical analyses for this end point

    Primary: Half-life T1/2

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    End point title
    		 Half-life T1/2 [8]
    End point description
    End point type
    Primary
    End point timeframe
    28 days
    Notes
    [8] - 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: Descriptive statistics, no statistical hypothesis verified.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    5 [9]
    6
    Units: hours
        arithmetic mean (standard deviation)
    326 ± 119
    303 ± 136
    Notes
    [9] - 1 patient was not evaluable for this parameter
    No statistical analyses for this end point

    Primary: T max

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    End point title
    		 T max [10]
    End point description
    End point type
    Primary
    End point timeframe
    28 days
    Notes
    [10] - 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: Descriptive statistics, no statistical hypothesis verified.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: hours
        median (full range (min-max))
    1.42 (1.40 to 2.70)
    2.04 (1.37 to 2.68)
    No statistical analyses for this end point

    Secondary: Changes in the Assessment of 14 Common COVID-19-Related Symptoms score per the assessment schedule

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    End point title
    		 Changes in the Assessment of 14 Common COVID-19-Related Symptoms score per the assessment schedule
    End point description
    Symptoms related to COVID-19 were assessed daily (pre-dose until Day 15) and on Day 22 and 29 using the 14 Common COVID-19-Related Symptom questionnaire. Symptoms were rated on either a 3- or 4-point ordinal scale and a total symptom score was calculated as the sum individual symptoms (range: 0 – 40).
    End point type
    Secondary
    End point timeframe
    Symptoms related to COVID-19 were assessed daily (pre-dose until Day 15) and on Day 22 and 29 using the 14 Common COVID-19-Related Symptom questionnaire. Data on day 8 is presented.
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: Total Covid-19 Related Symptoms Scores
        number (not applicable)
    -9.6
    -8.0
    No statistical analyses for this end point

    Secondary: Adverse events of special interest (AESIs)

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    End point title
    		 Adverse events of special interest (AESIs)
    End point description
    End point type
    Secondary
    End point timeframe
    by day 28
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: nr of AESI
    0
    0
    No statistical analyses for this end point

    Secondary: Infusion-related reactions (IRRs)

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    End point title
    		 Infusion-related reactions (IRRs)
    End point description
    End point type
    Secondary
    End point timeframe
    by day 28
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: nr of IRR
    0
    0
    No statistical analyses for this end point

    Secondary: Assessment of local tolerability at injection site (Visual Infusion Phlebitis score)

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    End point title
    		 Assessment of local tolerability at injection site (Visual Infusion Phlebitis score)
    End point description
    End point type
    Secondary
    End point timeframe
    at 30 min post injection
    End point values
    		 Ensovibep 225 mg Ensovibep 600 mg
    Number of subjects analysed
    6
    6
    Units: point
        arithmetic mean (standard deviation)
    0.2 ± 0.41
    0 ± 0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    MP0420 600 mg
    Reporting group description
    		 -

    Reporting group title
    MP0420 225 mg
    Reporting group description
    		 -

    Serious adverse events
    		 MP0420 600 mg MP0420 225 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MP0420 600 mg MP0420 225 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
    4 / 6 (66.67%)
    Investigations
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Bilirubin increased
    Additional description: Bilirubin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
    Additional description: Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    General disorders and administration site conditions
    Alcoholic hangover
    Additional description: Alcoholic hangover
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
    Additional description: Ear pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Muscle burning sensation
    Additional description: Muscle burning sensation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypophosphatemia
    Additional description: Hypophosphatemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Small sample size

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36214216
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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