VT-1161 is an orally available inhibitor of fungal CYP51 that has shown high potency and selectivity.
The molecule has successfully completed Phase 2b clinical testing for the treatment of recurrent vulvovaginal candidiasis (RVVC), a common mucosal infection that has no approved therapy in the United States, and onychomycosis . Because VT-1161 is highly selective for fungal CYP51, it may avoid the side effects that limit the use of current antifungals, including fluconazole and terbinafine, which are often prescribed for acute episodes of vulvovaginal candidiasis and onychomycosis, respectively. In addition, due to the high potency and therapeutic index of VT-1161, we believe that the agent may provide for a highly effective treatment of RVVC and achieve greater efficacy compared to current standard of care therapies for onychomycosis.
VT-1161 for Recurrent Vulvovaginal Candidiasis (RVVC)
VT-1161 is in development for the treatment of recurrent vulvovaginal candidiasis (RVVC), a common condition for which there are no approved therapies in the United States.
We successfully completed a Phase 2b study in RVVC (the REVIVE study) in December 2016 with the study meeting its primary endpoint of proportion of subjects with one or more culture-verified acute vulvovaginal candidiasis (AVVC) episodes through 48 weeks.
VT-1161 has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for the treatment of recurrent vulvovaginal candidiasis by the U.S. Food and Drug Administration.
“REVIVE” Study (REcurrent Vulvovaginal Candidiasis Inhibition: An Oral VT-1161 Tablet Evaluation): 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 (ClinicalTrials.gov identifier: NCT02267382)
VT-1161 for Onychomycosis
Separately, VT-1161 is also in development as an oral therapy for the treatment of onychomycosis, a common fungal infection of the nail for which current therapies are not optimal in respect to safety, tolerability, efficacy and duration of response.
We successfully completed the RENOVATE study, a Phase 2b study in onychomycosis of the toenail in December 2016, which met its primary endpoint of complete cure rates at 48 weeks.
“RENOVATE” Study (REstoring Nail: An Oral VT-1161 Tablet Evaluation): 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 Distal Lateral Subungual Onychomycosis of the Toenail (ClinicalTrials.gov identifier: NCT02267356)