Mycovia and Jiangsu Hengrui Medicine Partner for Anti-Fungal Treatment

Durham’s Mycovia Pharmaceuticals and Jiangsu Hengrui Medicine of China have announced a collaboration to develop and commercialize Mycovia’s drug candidate for treating recurrent yeast infections in women.

The drug, VT-1161, is an oral treatment for recurrent vulvovaginal candidiasis (RVVC) and onychomycosis for nail fungus. It has received Qualified Infectious Disease Product and Fast Track designations by the U.S. Food and Drug Administration. The designations provide incentives including extended patent protection and expedited regulatory reviews to companies developing new drugs that could satisfy unmet medical needs.

If VT-1161 is approved, it would become the first FDA-approved RVVC anti-fungal in the U.S. Existing RVVC treatments have been hampered by side effects, including risks to pregnancy.

“VT-1161 is an innovative antifungal candidate with a unique pharmacokinetic, efficacy and safety profile,” said Piaoyang Sun, chairman of the Hengrui board. “This partnership with Mycovia provides us an opportunity to better serve the antifungal medical needs for patients in China across a broad spectrum of infections, including superficial and invasive infections.”

NovaQuest Capital Management created Mycovia after the acquisition of Viamet Pharmaceuticals, with a central goal of creating breakthrough solutions for underserved fields of medicine. Mycovia is conducting Phase 3 trials of VT-1161 at 60 sites in the U.S., Europe and Japan. The placebo-controlled trials involving 300 randomized patients are to be completed in July 2020.

Hengrui logs $2.5 billion in annual sales and has over 130 ongoing clinical trials. The collaboration will land Mycovia development payments, milestones, and royalties in China. Hengrui gets the rights to exclusively release VT-1161 in China, where RVVC affects 29 million women.

The companies declined to disclose financial details of the agreement.