Scynexis’ Phase III Success Brings New Antifungal Class Closer To Approval
Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.
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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.
Scynexis highlights enrollment exceeding expectations in Phase III VVC trials; Daré prepares to enter Phase III to treat BV.
Positive top-line results from the Phase IIb DOVE study of Scynexis's SCY-078, and progress with a new intravenous formulation, suggest the US biotech's new triterpenoid could be the first of a new class of antifungal agents for serious infections.