Viamet study data demonstrates 'unprecedented' results in RVVC treatment
Viamet Pharmaceuticals announced the presentation of results from REVIVE, a Phase 2b clinical trial of VT-1161 in the treatment of patients with recurrent vulvovaginal candidiasis, at the Infectious Diseases Society for Obstetrics and Gynecology Annual Meeting in Park City, Utah. VT-1161 is a highly potent and selective, orally-administered inhibitor of fungal CYP51 that has demonstrated broad-spectrum activity against yeast, dermatophyte, endemic and multi-drug resistant fungal pathogens. The REVIVE study, presented by Jack Sobel, M.D., during an oral presentation on Thursday, August 10, demonstrated unprecedented efficacy and safety in patients with RVVC, a condition associated with a very high burden of disease and for which there are no approved therapies. The presentation titled, "Results from 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," was delivered by Dr. Sobel. In the intent-to-treat population, defined as all randomized subjects, the proportion of subjects with one or more vulvovaginal candidiasis episodes through 48 weeks ranged from 0-7% in the VT-1161 arms compared to 52% in the placebo arm. In the per protocol analysis, which included patients evaluable through 48 weeks, the recurrence rate of one or more vulvovaginal candidiasis episodes in the placebo arm was 66% while the four VT-1161 arms ranged from 0-11%. Throughout the study, VT-1161 was very well tolerated and there was a lower incidence of adverse events reported in all VT-1161 arms compared to placebo. VT-1161 also showed no evidence of adverse effects on laboratory parameters, which have been an issue for other oral treatment approaches for RVVC. In addition, VT-1161 displayed potent activity against a range of Candida species including C. glabrata, which is becoming more pronounced and which has shown resistance to other antifungal agents such as fluconazole.