Mycovia Pharmaceuticals has reported positive topline results from the Phase III ultraVIOLET study of its drug candidate, oteseconazole (VT1161), for treating patients with recurrent vulvovaginal candidiasis (RVVC).
Designed to be highly selective for its pathogenic target, Oteseconazole, a novel, investigational oral therapy, has lesser side effects and increased efficacy over the present standard of care for vulvovaginal candidiasis (VVC), fluconazole.
Known as chronic yeast infection, RVVC is a debilitating infectious condition with three or more episodes a year.
The study enrolled around 220 participants who were randomised to receive the treatment at 51 clinical sites in the US.
It evaluated the effectiveness of oteseconazole over 50 weeks in preventing recurring acute VVC episodes in women with a history of RVVC.
In addition, the trial compared the efficacy of oteseconazole with fluconazole for treating acute VVC episodes.
The trial’s primary endpoint was culture-verified recurrence from randomisation by week 50.
Data showed that the ultraVIOLET study met all primary and secondary endpoints.
The recurrence rate of Oteseconazole was at 5.1%, while the fluconazole to placebo recurrence rate was at 42.2%.
At day 14, the drug candidate was observed to be non-inferior to fluconazole in the resolution of signs and symptoms. It also prevented a recurring episode in 95% of women for a year.
Oteseconazole was also generally safe and well-tolerated.
Mycovia CEO Patrick Jordan said: “With positive data in hand from ultraVIOLET and our two pivotal Phase III VIOLET studies, we look forward to submitting a new drug application (NDA) for oteseconazole to the FDA in the first half of 2021.”
The latest data is similar to the company’s recently concluded two Phase III pivotal studies that had over 650 women from 11 countries.
In 2018, Mycovia commenced two Phase lll clinical trials called VIOLET to investigate the safety and efficacy of VT1161 for the treatment of patients with recurrent RVVC.