A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)

Viamet

Status and phase: Completed; Phase 2

Conditions: Candidiasis, Vulvovaginal

Treatments: Drug: VT-1161; Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01891331

VMT-VT-1161-CL-004

Details and patient eligibility

About

The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).

Enrollment: 55 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Females ≥18 and <65 years
• Clinical diagnosis of symptomatic acute VVC
• Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).
• At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
• A minimum composite vulvovaginal signs and symptoms score of ≥6
• must be be able to swallow capsules

Exclusion Criteria:

• Evidence of major organ system disease
• History of cervical cancer
• History of diabetes mellitus
• Pregnant
• Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason
• Recent use of drugs to treat vaginal infections
• Recent use of immunosuppressive therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

55 participants in 4 patient groups

VT-1161 300mg QD

Experimental group

Treatment:

Drug: VT-1161

VT-1161 600mg QD

Experimental group

Treatment:

Drug: VT-1161

VT-1161 600mg BID

Experimental group

Treatment:

Drug: VT-1161

Fluconazole 150mg

Active Comparator group

Treatment:

Drug: Fluconazole