Mycovia Extends Clinical Trials for Anti-Fungal Drug Candidate

Mycovia logo

Durham-based Mycovia Pharmaceuticals has extended its Phase 3 clinical trials of its lead drug candidate for treating recurrent yeast infections in women.

The trials will evaluate the effectiveness of Oteseconazole (VT-1161), an oral anti-fungal medicine the company is developing to treat recurrent vulvovaginal candidiasis (RVVC), over an additional 48 weeks.

RVVC is generally defined as three or more yeast infections per year. It affects nearly 138 million women worldwide each year -- about 5% to 8% of women. While the physical symptoms of RVVC – itching, irritation, soreness and damage to the skin – can be distressing, the emotional and psychological consequences can also affect quality of life.

There are currently no approved treatment options for RVVC in the U.S. today, despite the negative effects that the condition has on millions of women, according to Patrick Jordan, chief executive officer of Mycovia. “Women’s health is an underserved therapeutic area with significant unmet need.”

Candida-auris_CDC Image
Candida growing in a lab.
-- CDC image

Oteseconazole is getting the extended look after many trial patients were shown to be disease-free at the initial 48-week mark. The selective oral antifungal candidate exhibits fewer side effects and improved efficiency in comparison to current treatments for vaginal candidiasis. 

The company anticipates launching Oteseconazole in the U.S. next year, with the conclusion of three Phase 3 trials that are being conducted in 11 countries and enrolled 870 patients in December 2019. Two global trials (VIOLET) and one conducted in the U.S. (ultraVIOLET) are expecting topline data in the second half of 2020.

Oteseconazole is projected to launch in the U.S. in 2021. 

Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to support its potential as the first FDA-approved treatment for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Medicine Co., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan. 

It also licensed it to Gedeon Richter Plc., a Hungary-based pharmaceutical company, to commercialize and manufacture oteseconazole in Europe, Russia, the Commonwealth of Independent States, Latin America and Australia. 

Mycovia has also begun to explore the potential for its oral fungal inhibitors to treat a range of multi-drug-resistant fungal pathogens, including onychomycosis, a common infection of fingernails and toenails.

Lindsey Baron, NCBiotech Writer
scroll back to top of page