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Scynexis Prepares For NDA Filing With Second Phase III Success In VVC

 
• By Joseph Haas

Novel antifungal ibrexafungerp, a first-in-class triterpenoid, demonstrates ability to clear vulvovaginal candidiasis infections in second pivotal study; firm also looks to demonstrate efficacy in recurrent infections.

Detailed view of a sprinter getting ready to start. Selective focus.
With two successful Phase III studies, Scynexis is ready to file novel antifungal for approval

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...

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