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
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
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.
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