Objectives
VT-1161 is a novel oral selective inhibitor of fungal CYP51 and is highly potent against Candida species. Vulvovaginal candidiasis (VVC) is a common disorder with 75% of all women having at least one acute episode in their lifetime, and an estimated 5-8% suffering from recurrent VVC (RVVC). The objective of the study was to assess the potential of VT-1161 in treating acute VVC and to assess mycological recurrence under long-term (6-months) follow-up.
Methods
This was a Phase 2a, randomized, double-blind study to evaluate the efficacy and safety of 3 dosing regimens of oral VT-1161 compared to fluconazole in the treatment of patients with moderate-to-severe acute VVC (Identifier: NCT01891331). At baseline, patients were required to have a positive fungal KOH test and a score of 6 or greater on a signs and symptoms scale (maximum score of 18). Patients were randomly assigned to one of the following arms: 1) VT-1161 300 mg daily for 3 days; 2) VT-1161 600 mg daily for 3 days; 3) VT-1161 600 mg twice daily for 3 days or 4) fluconazole 150 mg administered as a single dose (per the US package insert) followed by placebo. Effective therapeutic cure was defined as a signs and symptoms score of 0 or 1 and a negative Candida culture.
Methods
This was a Phase 2a, randomized, double-blind study to evaluate the efficacy and safety of 3 dosing regimens of oral VT-1161 compared to fluconazole in the treatment of patients with moderate-to-severe acute VVC (Identifier: NCT01891331). At baseline, patients were required to have a positive fungal KOH test and a score of 6 or greater on a signs and symptoms scale (maximum score of 18). Patients were randomly assigned to one of the following arms: 1) VT-1161 300 mg daily for 3 days; 2) VT-1161 600 mg daily for 3 days; 3) VT-1161 600 mg twice daily for 3 days or 4) fluconazole 150 mg administered as a single dose (per the US package insert) followed by placebo. Effective therapeutic cure was defined as a signs and symptoms score of 0 or 1 and a negative Candida culture.
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