Scynexis Inc. followed up its Phase III success for ibrexafungerp in vulvovaginal candidiasis (VVC) last November with a second pivotal study hitting all endpoints. Now, the New Jersey biotech plans to file a new drug application for the first-in-class triterpenoid antifungal with continuing trials aimed at label expansions.
In topline data from the VANISH-306 study released 21 April, 63.3% of 188 modified intent-to-treat patients (p value ≤0.01) achieved cure – defined as complete resolution of all vaginal signs and symptoms – at a day 10 check in VVC, more commonly known as vaginal yeast infections. Scynexis said that if ibrexafungerp, a glucan synthase inhibitor, obtains US Food and Drug Administration approval, it will offer the first novel therapeutic option for VVC patients in over 20 years
