Scynexis Prepares For NDA Filing With Second Phase III Success In VVC
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.
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Phase III data showed that the first-in-class oral antifungal can prevent recurrence of vaginal yeast infections, a potentially valuable label addition to the current indication for acute treatment.
Scynexis sees a $300m-$400m commercial opportunity for the supplemental indication. A new therapeutic option is needed for oral step-down therapy because many Candida infections are resistant to oral fluconazole.
The first-in-class, novel antifungal for vaginal yeast infections will enter a genericized market, but also one with strong demand for better therapeutic options.