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Scynexis’ Phase III Success Brings New Antifungal Class Closer To Approval

 
• By Joseph Haas

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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Ibrexafungerp is being developed for acute and recurrent VVC

Scynexis Inc. took a significant step toward the approval of the first new class of antifungal agents since the 1980s with the successful Phase III VANISH-303 trial results in vulvovaginal candidiasis, commonly known as a yeast infection, for its ibrexafungerp (SCY-078) 7 November and now awaits data from a second pivotal study, expected next year, to file for US approval in acute VVC.

Ibrexafungerp is a first-in-class glucan synthase inhibitor being developed as both an oral and intravenous therapy for fungal infections caused by Candida and Aspergillus fungal pathogens

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