A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Study Overview
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Brief Summary
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VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Recurrent Vulvovaginal Candidiasis

Conditions
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Recurrent Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: VT-1161
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Clinical diagnosis of symptomatic acute VVC 3 or more episodes of acute VVC in the past 12 months Positive KOH Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening Composite vulvovaginal signs and symptoms score of <3 at Baseline Must be able to swallow tablets Key Exclusion Criteria: Evidence of major organ system disease Presence or a history of another vaginal or vulvar condition(s) History of cervical cancer Poorly controlled diabetes mellitus Pregnant Recent use of topical or systemic antifungal drugs Recent use of immunosuppressive or system corticosteroid therapies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VT-1161 Low-dose 3-month<br>1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks | Drug: VT-1161<br> <br> |
| Experimental: VT-1161 Low-dose 6-month<br>1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks | Drug: VT-1161<br> <br> |
| Experimental: VT-1161 High-dose 3-month<br>2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks | Drug: VT-1161<br> <br> |
| Experimental: VT-1161 High-dose 24-week<br>2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks | Drug: VT-1161<br> <br> |
| Placebo Comparator: Placebo<br>2 placebo tablets once daily for 7 days, then once weekly for 23 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome. 0 = none (complete absence of any sign or symptom) = mild (slight) = moderate (definitely present) = severe (marked, intense) | 48 Weeks |