28 February 2019 - - US-based Mycovia Pharmaceuticals, a company developing therapies in women's health and dermatology, has initiated an additional Phase 3 clinical study called ultraVIOLET to evaluate the safety and efficacy of lead candidate, VT-1161, and its ability to treat acute infections in women with recurrent vulvovaginal candidiasis compared to fluconazole, the current standard of care, the company said.

Mycovia has reached agreement on pivotal study designs with the US Food and Drug Administration, European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency.

The additional randomised, double-blind ultraVIOLET Phase 3 trial will be conducted in the United States with approximately 45 sites and 180 randomized patients.

The company expects to complete all three Phase 3 trials of the RVVC program in the second half of 2020 in anticipation of regulatory submissions.

VT-1161 is an orally available inhibitor of fungal CYP51 being developed by Mycovia for the treatment of recurrent vulvovaginal candidiasis and onychomycosis. VT-1161 is designed to have greater selectivity, fewer side effects and improved potency.

Recurrent vulvovaginal candidiasis is a debilitating, chronic infectious condition that affects ms of women. Primary symptoms include vaginal itching, burning, irritation and inflammation.

Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain.

RVVC impacts quality of life, to a degree comparable to asthma and worse than diseases such as headache and migraine, yet despite the high prevalence, there are currently no agents in the United States approved to treat the condition.

Mycovia is in developing targeted therapies in women's health and dermatology. The company was formed in 2018 following the acquisition of Viamet Pharmaceuticals by NovaQuest Capital Management.

NovaQuest Capital Management is an investor in life sciences and healthcare through its BioPharma and Private Equity strategies.