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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects with Acute Vulvovaginal Candidiasis

    Summary
    EudraCT number
    		 2018-004492-12
    Trial protocol
    		 BG  
    Global end of trial date
    07 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2021
    First version publication date
    26 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SCY-078-306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 107521
    Sponsors
    Sponsor organisation name
    SCYNEXIS, Inc.
    Sponsor organisation address
    1 Evertrust Plaza, 13th Floor, Jersey City, United States, NJ 07302
    Public contact
    VANISH Study Team, SCYNEXIS, Inc., +1 201884 5485, info@scynexis.com
    Scientific contact
    VANISH Study Team, SCYNEXIS, Inc., +1 201884 5485, info@scynexis.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
    08 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of oral ibrexafungerp versus placebo in subjects with acute vulvovaginal candidiasis (AVVC) by comparing the clinical outcomes of ibrexafungerp and placebo. Efficacy was defined as the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the TOC visit.
    Protection of trial subjects
    The ICH issued guidelines to provide protection for human subjects in clinical investigations. The ICH E6 GCP guideline establishes the general requirements for informed consent. Each subject was provided with oral and written information in a language they could understand that described the nature and duration of the study. Before undergoing screening, each subject must have consented in writing to study participation. In case of a minor and according to the local definition (eg, below 16 or 18 years of age), the parent or legal representative should have also signed and dated the ICF.
    Background therapy
    		 All prior and concomitant medications including Rescue Antifungal medication were coded using the World Health Organization (WHO) Drug Dictionary (WHODrug) Global Sept 2018 B3 and summarized by treatment group for all subjects in the ITT and mITT sets.
    Evidence for comparator
    		 No active comparator, placebo controlled study
    Actual start date of recruitment
    07 Jun 2019
    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
    United States: 171
    Country: Number of subjects enrolled
    Bulgaria: 278
    Worldwide total number of subjects
    449
    EEA total number of subjects
    278
    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)
    445
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled into the study and were randomly assigned in a 2:1 ratio to - Ibrexafungerp: oral 300-mg dose BID for 1 day - Placebo: oral ibrexafungerp matching placebo BID for 1 day

    Pre-assignment
    Screening details
    		 Screening and baseline visits may have occurred on the same day. A total number of 449 subjects were enrolled in the study: 298 subjects to ibrexafungerp and 151 subjects to placebo.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This was a double-blind, double-dummy study. The study drugs were identical in number and appearance. Blinding was maintained throughout the study by use of active or placebo dosage forms of similar appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ibrexafungerp
    Arm description
    		 The study consisted of a screening visit, a baseline visit on Day 1 (the screening and baseline visits may have occurred on the same day), a TOC visit on Day 11 (± 3 days or Day 8 to Day 14), and a FU visit on Day 25 (± 4 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibrexafungerp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibrexafungerp 150-mg tablets administered orally as 2 tablets (300 mg) BID for 1 day.

    Arm title
    		 Placebo
    Arm description
    		 The placebo product matching ibrexafungerp was supplied as a tablet matching the size and appearance of the active tablet. The tablet formulation contained silicified microcrystalline cellulose, crospovidone, mannitol, colloidal silicon dioxide, magnesium stearate (nonbovine), and butylated hydroxyanisole.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral ibrexafungerp matching placebo BID for 1 day.

    Number of subjects in period 1
    		Ibrexafungerp Placebo
    Started
    298
    151
    Completed
    246
    102
    Not completed
    52
    49
         Adverse event, non-fatal
    3
    -
         Other
    48
    47
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ibrexafungerp
    Reporting group description
    		 The study consisted of a screening visit, a baseline visit on Day 1 (the screening and baseline visits may have occurred on the same day), a TOC visit on Day 11 (± 3 days or Day 8 to Day 14), and a FU visit on Day 25 (± 4 days).

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo product matching ibrexafungerp was supplied as a tablet matching the size and appearance of the active tablet. The tablet formulation contained silicified microcrystalline cellulose, crospovidone, mannitol, colloidal silicon dioxide, magnesium stearate (nonbovine), and butylated hydroxyanisole.

    Reporting group values
    		 Ibrexafungerp Placebo Total
    Number of subjects
    		 298 151 449
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 296 149 445
        From 65-84 years
    		 2 2 4
    Age continuous
    Units: years
        median (full range (min-max))
    		 33 (18 to 67) 32 (18 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 298 151 449
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Intent-to-treat (ITT) set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who signed the ICF and received at least 1 dose of study drug.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least 1 dose of study drug and who had at least 1 postbaseline evaluation.

    Subject analysis set title
    Modified intent-to-treat (mITT) set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who had a positive culture for Candida species at baseline, a diagnosis of symptomatic AVVC at baseline and received at least 1 dose of study drug.

    Subject analysis sets values
    		 Intent-to-treat (ITT) set Safety set Modified intent-to-treat (mITT) set
    Number of subjects
    449
    449
    272
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    445
    445
    270
        From 65-84 years
    4
    4
    2
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    449
    449
    272
        Male
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Ibrexafungerp
    Reporting group description
    		 The study consisted of a screening visit, a baseline visit on Day 1 (the screening and baseline visits may have occurred on the same day), a TOC visit on Day 11 (± 3 days or Day 8 to Day 14), and a FU visit on Day 25 (± 4 days).

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo product matching ibrexafungerp was supplied as a tablet matching the size and appearance of the active tablet. The tablet formulation contained silicified microcrystalline cellulose, crospovidone, mannitol, colloidal silicon dioxide, magnesium stearate (nonbovine), and butylated hydroxyanisole.

    Subject analysis set title
    Intent-to-treat (ITT) set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who signed the ICF and received at least 1 dose of study drug.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least 1 dose of study drug and who had at least 1 postbaseline evaluation.

    Subject analysis set title
    Modified intent-to-treat (mITT) set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who had a positive culture for Candida species at baseline, a diagnosis of symptomatic AVVC at baseline and received at least 1 dose of study drug.

    Primary: Clinical Outcome at the TOC Visit (mITT)

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    End point title
    		 Clinical Outcome at the TOC Visit (mITT)
    End point description
    The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the TOC visit, was conducted on the mITT set using a CMH test for ibrexafungerp versus placebo.
    End point type
    Primary
    End point timeframe
    At TOC visit
    End point values
    		 Ibrexafungerp Placebo
    Number of subjects analysed
    188
    84
    Units: percent
    number (not applicable)
        Clinical cure, n (%)
    63.3
    44
        Clinical failure, n (%)
    36.7
    56
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test has been used for the statistical analysis.
    Comparison groups
    Ibrexafungerp v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.073
         upper limit
    		 1.783

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events have been recorded at baseline visit on Day 1, a TOC visit on Day 11 (± 3 days or Day 8 to Day 14), and a FU visit on Day 25 (± 4 days).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Ibrexafungerp
    Reporting group description
    		 The study consisted of a screening visit, a baseline visit on Day 1 (the screening and baseline visits may have occurred on the same day), a TOC visit on Day 11 (± 3 days or Day 8 to Day 14), and a FU visit on Day 25 (± 4 days).

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo product matching ibrexafungerp was supplied as a tablet matching the size and appearance of the active tablet. The tablet formulation contained silicified microcrystalline cellulose, crospovidone, mannitol, colloidal silicon dioxide, magnesium stearate (nonbovine), and butylated hydroxyanisole.

    Serious adverse events
    		 Ibrexafungerp Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 151 (0.66%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Gastrointestinal bacterial infection
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 151 (0.66%)
         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: 5%
    Non-serious adverse events
    		 Ibrexafungerp Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 298 (19.46%)
    14 / 151 (9.27%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 298 (7.38%)
    11 / 151 (7.28%)
         occurrences all number
    22
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    28 / 298 (9.40%)
    1 / 151 (0.66%)
         occurrences all number
    28
    1
    Nausea
         subjects affected / exposed
    25 / 298 (8.39%)
    4 / 151 (2.65%)
         occurrences all number
    25
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2019
    The total number of subjects randomized was increased (to an estimated maximum of 470 subjects) to achieve the required 282 evaluable subjects due to higher than anticipated rate of “no growth” samples at baseline (above 20%).

    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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