Viamet Pharmaceuticals has reported positive results from a Phase II clinical trial (REVIVE) of VT-1161 to treat recurrent vulvovaginal candidiasis (RVVC) patients.
T-1161 is a potent, selective and oral inhibitor of fungal CYP51 and blocks the production of ergosterol that is considered an important component of fungal cell membrane.
The results that indicated efficacy and safety of the investigational candidate were presented by the trial’s clinical investigator Dr Jack Sobel at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) annual meeting held in Utah, US.
Viamet Pharmaceuticals CEO Robert Schotzinger said: “VT-1161 is highly potent against a broad spectrum of Candida species, the primary fungal pathogens responsible for RVVC, and has clinically demonstrated a durable response against re-infection.
“We believe that VT-1161 has the potential to be a best-in-class treatment option for patients suffering from RVVC and the first FDA approved treatment for this very common disease.”
The randomised, double-blind, placebo-controlled Phase II trial assessed 150mg and 300mg dose levels of VT-1161 in 215 subjects over 48 weeks at 32 US centres.
REVIVE’s primary endpoint of proportion of subjects with one or more culture-verified, vulvovaginal candidiasis episodes over 48 weeks was 0%-7% when compared to 52% with placebo.
The recurrence rate of one or more vulvovaginal candidiasis episodes was observed to be 0%-11% with the investigational candidate and 66% with placebo.
Additionally, VT-1161 was found to be well-tolerated, with a low incidence of adverse events and no evidence of adverse effects on laboratory parameters.
VT-1161 has secured qualified infectious disease product (QIDP) and fast-track designations from the US Food and Drug Administration (FDA) for RVVC.