Signs Of Life In The Bacterial Vaginosis, Vulvovaginal Candidiasis Pipeline
Scynexis highlights enrollment exceeding expectations in Phase III VVC trials; Daré prepares to enter Phase III to treat BV.
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Oteseconazole prevented recurrent VVC in two Phase III studies but Phase III data in acute treatment of VVC episodes in women with RVVC, also due this month, are needed to file for US FDA approval in the first half of 2021.
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.
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.