Viamet initiates phase 2 clinical trial of antifungal agent VT-1161 for treatment of vulvovaginal candidiasis

Sep 7 2013

Viamet Pharmaceuticals, Inc. announced today the initiation of the phase 2 clinical program for its antifungal agent VT-1161. The initial phase 2 study is designed to evaluate the safety and efficacy of VT-1161 in the treatment of vulvovaginal candidiasis (VVC) and is being conducted at leading clinical centers in the United States. VT-1161 has been shown in preclinical studies to potently inhibit in a selective manner a wide range of fungal pathogens causing human disease. In previous phase 1 clinical studies, VT-1161 demonstrated good safety, tolerability and pharmacokinetics.

“It is exciting to move the first compound from our antifungal franchise into phase 2 clinical trials”

It is estimated that 5-8% of women suffer from recurring episodes of vulvovaginal candidiasis during their reproductive years, a condition called recurrent vulvovaginal candidiasis, or RVVC. There are currently no approved agents in the United States to treat these recurring and difficult infections. Over-the-counter topical therapies, while effective for acute and uncomplicated episodes of VVC, are typically not effective against recurrent infections. There is a significant unmet medical need for a safe and effective, oral therapy to treat RVVC.

"It is exciting to move the first compound from our antifungal franchise into phase 2 clinical trials", said Robert Schotzinger, M.D., Ph.D., President and Chief Executive Officer of Viamet. "VT-1161 is a novel, potent and highly selective fungal CYP51 inhibitor that is active against a wide range of fungal pathogens. We believe that the efficacy and safety characteristics of VT-1161 demonstrated to date make it a very promising oral therapy for the treatment of multiple types of fungal infection in humans, including RVVC, onychomycosis, and a range of more serious and invasive fungal illnesses."

VT-1161 is one of several novel, small molecule compounds currently under development at Viamet for the treatment of fungal infections. VT-1129 is a potent and selective, oral, preclinical development candidate for the treatment of cryptococcal meningitis and other serious invasive fungal diseases. Several additional injectable and orally-administered molecules are in early-stage development for the treatment of invasive yeast and mold infections commonly encountered in the hospital. All of the Viamet antifungal candidates have been discovered and developed internally utilizing the company's Metallophile^® Technology platform.