Phase III ultraVIOLET clinical trial for VT 1161 meets primary endpoints for vulvovaginal candidiasis.- Mycovia Pharma

Mycovia Pharmaceuticals announced positive topline results from its Phase III ultraVIOLET clinical trial for VT 1161 (oteseconazole), its drug candidate for treating patients with recurrent vulvovaginal candidiasis (RVVC). The ultraVIOLET study met all primary and secondary endpoints. In particular, the primary endpoint (culture-verified recurrence from randomization through Week 50). Oteseconazole showed a recurrence rate of 5.1%, fluconazole to placebo recurrence rate of 42.2% (p-value < 0.001). Oteseconazole was non-inferior to fluconazole in the resolution of signs and symptoms at Day 14. Culture-verified recurrence from Day 14 through Week 50 showed a recurrence rate of 3.8%, fluconazole to placebo recurrence rate of 41.1% (p-value < 0.001). Oteseconazole prevented a recurring episode in 95% of women for approximately one year. Oteseconazole was generally safe and well tolerated; treatment-emergent adverse events were similar across treatment groups. The ultraVIOLET data replicates findings from Mycovia’s recently completed two Phase III pivotal studies. The global studies included more than 650 women from 11 countries. Subjects participating in the VIOLET studies in the U.S., who remained infection-free at their Week 48 visit, were offered the opportunity to participate in an extension study to be monitored for an additional 48 weeks, to further define the long-term protective profile of oteseconazole. Eighty-five subjects are currently enrolled in the extension study. Comment: RVVC, commonly known as chronic yeast infection, is a debilitating infectious condition defined as three or more episodes per year. Oteseconazole is designed to be highly selective for its pathogenic target, with fewer side effects and improved efficacy over current treatment options, including the current standard of care for vulvovaginal candidiasis (VVC), fluconazole.