Mycovia Pharmaceuticals announces publication of positive study results of oteseconazole for the treatment of acute vulvovaginal candidiasis.

Mycovia, an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, announced positive topline results from its two pivotal Phase III VIOLET clinical trials for oteseconazole, its drug candidate for treating patients with recurrent vulvovaginal candidiasis (RVVC). RVVC, commonly known as chronic yeast infection, is a debilitating infectious condition that affects nearly 138 million women worldwide each year. RVVC is defined as three or more episodes in one year. Topline data shows that Mycovia’s pivotal Phase III VIOLET studies successfully met their primary endpoint (p-value <0.001), defined as the proportion of subjects with one or more culture-verified acute vulvovaginal candidiasis vvc episodes during the maintenance phase post-randomization through week 48 in the intent-to-treat population. additionally all key secondary endpoints met statistical significance p-value><0.001) through week 48. oteseconazole also protected greater than 90 of participants from having a recurrence during the maintenance phase. oteseconazole was generally safe and well tolerated. m treatment-emergent adverse events teaes were similar across treatment and placebo groups. related teaes were also balanced and included: headache><1%, nausea><1%, and diarrhea><1%. no drug-related severe adverse events saes were reported. the violet studies evaluated the safety of oteseconazole and its ability to prevent recurring episodes of vvc over 48 weeks in subjects with an established disease history of at least three episodes of acute vvc in the past 12 months. in addition to violet mycovia is also currently evaluating the clinical effectiveness of oteseconazole in women with rvvc in a phase iii ultraviolet clinical trial a u.s. study evaluating the safety and efficacy of oteseconazole in addition to its ability to treat acute episodes of vvc in women with rvvc compared to fluconazole. mycovia expects to have topline results from ultraviolet in late 2020 and data from these three clinical studies will be submitted as part of its planned nda submission in the first half of 2021.>