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    Clinical Trial Results:
    A Phase Ib/IIa open-label, repeated dose, metabolic balance study of FE 203799 in patients with short bowel syndrome

    Summary
    EudraCT number
    		 2017-002487-41
    Trial protocol
    		 DK  
    Global end of trial date
    28 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2021
    First version publication date
    03 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLY-321-2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GLyPharma Therapeutic Inc.
    Sponsor organisation address
    1188 Avenue Union, Suite 504/505, Montreal, Canada, H3B 0E5
    Public contact
    Christian Meyer, GLyPharma Therapeutic Inc. (a wholly owned subsidiary of VectivBio Holding AG), 0041 796543455, christian.meyer@vectivbio.com
    Scientific contact
    Christian Meyer, GLyPharma Therapeutic Inc. (a wholly owned subsidiary of VectivBio Holding AG), 0041 796543455, christian.meyer@vectivbio.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
    16 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of FE 203799 in patients with short bowel syndrome (SBS)
    Protection of trial subjects
    This trial was conducted in accordance with the ICH GCP guidelines, including the archiving of essential documents, and with the ethical principles that have their origin in the Declaration of Helsinki. Personal data included in the clinical trial report were collected and processed in accordance with the EU General Data Protection Regulation.
    Background therapy
    		 None, this was a one-arm trial.
    Evidence for comparator
    		 There was no comparator.
    Actual start date of recruitment
    02 May 2018
    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
    Denmark: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    4
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects were recruited at a single trial centre in Denmark.

    Pre-assignment
    Screening details
    		 A total of 9 subjects were screened and 8 were enrolled in the trial. The reason for the screen failure was due to not fulfilling inclusion criteria 3 (average faecal wet weight excretion of ≥1500 g/day during the baseline balance study) and 4 (average urine production <2000 mL/day during the baseline balance study).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable as this was a one-arm open-label trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SBS-II
    Arm description
    		 Subjects with short bowel syndrome and intestinal insufficiency
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apraglutide
    Investigational medicinal product code
    FE 203799
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The subjects were to receive a subcutaneous dose of 5 mg FE 203799 once weekly for 4 weeks

    Arm title
    		 SBS-IF
    Arm description
    		 Subjects with short bowel syndrome and intestinal failure
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apraglutide
    Investigational medicinal product code
    FE 203799
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The subjects were to receive a subcutaneous dose of 5 mg FE 203799 once weekly for 4 weeks

    Number of subjects in period 1
    		SBS-II SBS-IF
    Started
    4
    4
    Completed
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SBS-II
    Reporting group description
    		 Subjects with short bowel syndrome and intestinal insufficiency

    Reporting group title
    SBS-IF
    Reporting group description
    		 Subjects with short bowel syndrome and intestinal failure

    Reporting group values
    		 SBS-II SBS-IF Total
    Number of subjects
    		 4 4 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 2 2 4
        From 65-84 years
    		 2 2 4
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.50 ( 3.40 ) 57.50 ( 20.00 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 5
        Male
    		 2 1 3
    Race
    Units: Subjects
        White
    		 4 4 8
    Body weight
    Units: kg
        arithmetic mean (standard deviation)
    		 83.20 ( 18.50 ) 62.50 ( 11.20 ) -
    Body mass index
    A subject's weight in kilograms divided by the square of height in meters
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 28.60 ( 5.10 ) 22.70 ( 4.20 ) -
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set comprised all subjects who had received at least 1 dose of trial drug and who, at least, had provided data for at least 1 post-baseline efficacy or pharmacokinetic endpoint.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set comprised all subjects who received an investigational medicinal product injection at least once.

    Subject analysis sets values
    		 Full analysis set Safety analysis set
    Number of subjects
    8
    8
    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)
    4
        From 65-84 years
    4
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.00 ( 13.80 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    3
    Race
    Units: Subjects
        White
    8
    Body weight
    Units: kg
        arithmetic mean (standard deviation)
    72.80 ( 18.00 )
    ( )
    Body mass index
    A subject's weight in kilograms divided by the square of height in meters
    Units: kg/m2
        arithmetic mean (standard deviation)
    25.60 ( 5.40 )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    SBS-II
    Reporting group description
    		 Subjects with short bowel syndrome and intestinal insufficiency

    Reporting group title
    SBS-IF
    Reporting group description
    		 Subjects with short bowel syndrome and intestinal failure

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set comprised all subjects who had received at least 1 dose of trial drug and who, at least, had provided data for at least 1 post-baseline efficacy or pharmacokinetic endpoint.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set comprised all subjects who received an investigational medicinal product injection at least once.

    Primary: Adverse events

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    End point title
    		 Adverse events [1]
    End point description
    Number of subjects experiencing adverse events
    End point type
    Primary
    End point timeframe
    Treatment-emergent adverse events were defined as those with onset after dosing at visit 3 until the end-of-trial visit (visit 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: No formal statistical comparisons of adverse event incidence rates between the reporting groups were performed.
    End point values
    		 SBS-II SBS-IF Safety analysis set
    Number of subjects analysed
    4
    4
    8
    Units: Subjects
    4
    4
    8
    No statistical analyses for this end point

    Secondary: Absolute change in faecal excretion of wet weight

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    End point title
    		 Absolute change in faecal excretion of wet weight
    End point description
    Absolute change in faecal excretion of wet weight from baseline to end of treatment
    End point type
    Secondary
    End point timeframe
    Over 72 hours from baseline to end of treatment
    End point values
    		 SBS-II SBS-IF Full analysis set
    Number of subjects analysed
    4
    4
    8
    Units: g/day
        arithmetic mean (standard deviation)
    -866.4 ( 835.0 )
    -492.5 ( 339.8 )
    -679.4 ( 623.1 )
    Statistical analysis title
    		 Absolute change in faecal wet weight excretion
    Statistical analysis description
    An analysis of the mean change from baseline to end of treatment for the full population of 8 subjects was derived using a paired t-test and the corresponding mean value together with the 95% confidence interval.
    Comparison groups
    SBS-II v SBS-IF
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0177
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -679.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1200.4
         upper limit
    		 -158.5

    Secondary: Absolute change in urinary output

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    End point title
    		 Absolute change in urinary output
    End point description
    Absolute change in urinary output from baseline to end of treatment
    End point type
    Secondary
    End point timeframe
    Over 72 hours from baseline to end of treatment
    End point values
    		 SBS-II SBS-IF Full analysis set
    Number of subjects analysed
    4
    4
    8
    Units: g/day
        arithmetic mean (standard deviation)
    560.0 ( 614.3 )
    560.0 ( 646.2 )
    560.0 ( 583.7 )
    Statistical analysis title
    		 Absolute change in urinary output
    Statistical analysis description
    An analysis of the mean change from baseline to end of treatment for the full population of 8 subjects was derived using a paired t-test and the corresponding mean value together with the 95% confidence interval.
    Comparison groups
    SBS-II v SBS-IF
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0301
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    560
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 72
         upper limit
    		 1048

    Secondary: Absolute change in absorption of wet weight

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    End point title
    		 Absolute change in absorption of wet weight
    End point description
    Absolute change in absorption of wet weight from baseline to end of treatment
    End point type
    Secondary
    End point timeframe
    Over 72 hours from baseline to end of treatment
    End point values
    		 SBS-II SBS-IF Full analysis set
    Number of subjects analysed
    4
    4
    8
    Units: g/day
        arithmetic mean (standard deviation)
    888.0 ( 903.8 )
    593.3 ( 349.5 )
    740.7 ( 653.6 )
    Statistical analysis title
    		 Absolute change in absorption of wet weight
    Statistical analysis description
    An analysis of the mean change from baseline to end of treatment for the full population of 8 subjects was derived using a paired t-test and the corresponding mean value together with the 95% confidence interval.
    Comparison groups
    SBS-II v SBS-IF
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.015
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    740.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 194.2
         upper limit
    		 1287.2

    Secondary: Absolute change in energy absorption

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    End point title
    		 Absolute change in energy absorption
    End point description
    Absolute change in energy absorption from baseline to end of treatment
    End point type
    Secondary
    End point timeframe
    Over 72 hours from baseline to end of treatment
    End point values
    		 SBS-II SBS-IF Full analysis set
    Number of subjects analysed
    4
    4
    8
    Units: kJ/day
        arithmetic mean (standard deviation)
    1356.2 ( 1497.5 )
    833.4 ( 521.0 )
    1094.8 ( 1075.0 )
    Statistical analysis title
    		 Absolute change in energy absorption
    Statistical analysis description
    An analysis of the mean change from baseline to end of treatment for the full population of 8 subjects was derived using a paired t-test and the corresponding mean value together with the 95% confidence interval.
    Comparison groups
    SBS-II v SBS-IF
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0236
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    1094.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 196.1
         upper limit
    		 1993.6

    Secondary: Absolute change in sodium absorption

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    End point title
    		 Absolute change in sodium absorption
    End point description
    Absolute change in sodium absorption from baseline to end of treatment
    End point type
    Secondary
    End point timeframe
    Over 72 hours from baseline to end of treatment
    End point values
    		 SBS-II SBS-IF Full analysis set
    Number of subjects analysed
    4
    4
    8
    Units: mmol/day
        arithmetic mean (standard deviation)
    66.3 ( 41.6 )
    9.8 ( 18.1 )
    38.0 ( 42.3 )
    Statistical analysis title
    		 Absolute change in sodium absorption
    Statistical analysis description
    An analysis of the mean change from baseline to end of treatment for the full population of 8 subjects was derived using a paired t-test and the corresponding mean value together with the 95% confidence interval.
    Comparison groups
    SBS-II v SBS-IF
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0386
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    38.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.6
         upper limit
    		 73.5

    Secondary: Absolute change in potassium absorption

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    End point title
    		 Absolute change in potassium absorption
    End point description
    Absolute change in potassium absorption from baseline to end of treatment
    End point type
    Secondary
    End point timeframe
    Over 72 hours from baseline to end of treatment
    End point values
    		 SBS-II SBS-IF Full analysis set
    Number of subjects analysed
    4
    4
    8
    Units: mmol/day
        arithmetic mean (standard deviation)
    19.9 ( 20.9 )
    16.2 ( 15.0 )
    18.1 ( 17.0 )
    Statistical analysis title
    		 Absolute change in potassium absorption
    Statistical analysis description
    An analysis of the mean change from baseline to end of treatment for the full population of 8 subjects was derived using a paired t-test and the corresponding mean value together with the 95% confidence interval.
    Comparison groups
    SBS-II v SBS-IF
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0196
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    18.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.9
         upper limit
    		 32.3

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AE) s were recorded from screening until the final visit 4-6 weeks after the last dose.
    Adverse event reporting additional description
    An AE having onset on or after the day of the first administration of trial drug was considered treatment emergent. Adverse events were reported for the safety analysis set, comprising all subjects who received a treatment injection at least once.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    SBS-II
    Reporting group description
    		 Subjects with short bowel syndrome and intestinal insufficiency

    Reporting group title
    SBS-IF
    Reporting group description
    		 Subjects with short bowel syndrome and intestinal failure

    Serious adverse events
    		 SBS-II SBS-IF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SBS-II SBS-IF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    Injection site pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Injection site erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Energy increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Thirst decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Early satiety
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Investigations
    Gastrointestinal stoma output decreased
         subjects affected / exposed
    3 / 4 (75.00%)
    3 / 4 (75.00%)
         occurrences all number
    3
    3
    Gastrointestinal stoma output abnormal
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    1
    Weight increased
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Stoma complication
         subjects affected / exposed
    3 / 4 (75.00%)
    3 / 4 (75.00%)
         occurrences all number
    4
    3
    Gastrointestinal stoma complication
         subjects affected / exposed
    3 / 4 (75.00%)
    2 / 4 (50.00%)
         occurrences all number
    3
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 4 (50.00%)
    4 / 4 (100.00%)
         occurrences all number
    2
    5
    Abdominal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    1
    Flatulence
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    1
    Constipation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Rectal discharge
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Fluid retention
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Dehydration
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Apr 2018
    The dose was reduced from 25 mg to 5 mg, to change the approach for the first dosing in patients to a lower dose, which would be optimal for a first-in-patient trial, avoiding exposure of patients to potentially unnecessary elevated concentrations of the active compound. The change was based on thorough analyses of older and recent pharmacology data collected in nonclinical studies which suggested that a lower dose of FE 203799, such as 5 mg, could also show pharmacological activity.
    06 Dec 2018
    The substantial changes of the amendment were: • The possibility to conduct interim analyses during the trial, if deemed necessary by the sponsor, was introduced. It was stated that any potential influence of interim analysis on the continued trial conduct would be minimised by appropriate measures. • The sponsor of the trial was changed from GlyPharma Therapeutic Inc. to GlyPharma Therapeutic Inc. (a wholly owned subsidiary of Therachon AG, Aeschenvorstadt 36, CH-4051 Basel Switzerland). Consequently, the sponsor medical officer and list of trial personnel were changed. • An additional laboratory was included in order to analyse all exploratory biomarkers.
    01 Feb 2019
    The substantial change of the amendment was: • The inclusion of SBS patients with intestinal insufficiency (IF) • Addition of an inclusion criterion for male contraception • Change of exclusion criterion 16: Patients with changes in the use of systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or other biologic therapy/immune modifiers within 3 months of screening were to be excluded from the protocol
    27 Jun 2019
    The substantial changes of the amendment were: • A change in the company that owns the sponsor, GlyPharma Therapeutic Inc., from Therachon AG to VectivBio Holding AG. • A change of company name of one of the analysis laboratories was dated 09-Apr-2018 and approved prior to enrolment of the first patient.

    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.
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