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

Viamet

Status and phase: Completed; Phase 2

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Drug: VT-1161; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267382

VMT-VT-1161-CL-006

Details and patient eligibility

About

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.

Enrollment: 254 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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254 participants in 5 patient groups, including a placebo group

VT-1161 Low-dose 3-month

Experimental group

Description:

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

Treatment:

Drug: VT-1161

VT-1161 Low-dose 6-month

Experimental group

Description:

1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks

Treatment:

Drug: VT-1161

VT-1161 High-dose 3-month

Experimental group

Description:

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

Treatment:

Drug: VT-1161

VT-1161 High-dose 24-week

Experimental group

Description:

2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks

Treatment:

Drug: VT-1161

Placebo

Placebo Comparator group

Description:

2 placebo tablets once daily for 7 days, then once weekly for 23 weeks

Treatment:

Drug: Placebo