Topline results were announced from two phase 3 trials evaluating oteseconazole (VT-1161; Mycovia Pharmaceuticals) for the treatment of recurrent vulvovaginal candidiasis (VVC).
Oteseconazole is a novel oral inhibitor of fungal CYP51. The Company believes that its high potency and selectivity for fungal CYP51 may avoid the side effects that limit the use of current antifungals (eg, fluconazole, terbinafine) for the treatment of VVC.
The 2 randomized, double-blind, placebo-controlled trials (NCT03562156, NCT03561701) evaluated the efficacy and safety of oteseconazole for the treatment of recurrent VVC in female patients aged 12 years and older with at least 3 episodes of acute VVC in the past 12 months. Patients were randomized to receive either placebo or oteseconazole 150mg capsules orally once daily for 7 days, then once weekly for 11 weeks starting on day 14, followed by a 36-week follow-up period.
Findings showed that both trials met the primary end point (P <.001), defined as the proportion of patients with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through week 48) in the intent-to-treat population. Greater than 90% of patients treated with oteseconazole were protected from a recurrent VVC episode during the maintenance phase.
“Our results show that oteseconazole was able to prevent a recurring infection over the course of these 48-week studies in 96% and 93% of women,” said Stephen Brand, PhD, Chief Development Officer at Mycovia. “In addition, these studies provided further support for the excellent safety profile, clearly differentiating oteseconazole from other antifungal agents.”
The Food and Drug Administration (FDA) previously granted Qualified Infectious Disease Product and Fast Track designations to oteseconazole for this indication.
In addition, the Company is currently evaluating the safety and efficacy of oteseconazole compared with fluconazole in the phase 3 ultraVIOLET study for treating acute VVC episodes in patients with recurrent VVC. Oteseconazole is also being investigated for the treatment of onychomycosis in the phase 2 RENOVATE study.
For more information visit mycovia.com.
Mycovia Pharmaceuticals announces positive topline results from phase 3 VIOLET studies of oteseconazole in patients with recurrent vulvovaginal candidiasis. [press release]. Durham, NC: Mycovia Pharmaceuticals, Inc; December 9, 2020.