Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis

Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced it has submitted its New Drug Application (NDA) for oteseconazole, an oral antifungal product for the treatment of recurrent vulvovaginal candidiasis (RVVC). Also known as chronic yeast infection, RVVC is a debilitating infectious condition defined as three or more episodes per year. Although RVVC affects nearly 138 million women worldwide each year and 6 million women in the U.S. alone, there are currently no FDA-approved treatments.

“We are thrilled to take this pivotal step in our journey to bring oteseconazole to millions of women suffering from RVVC,” said Patrick Jordan, CEO of Mycovia Pharmaceuticals and Partner at NovaQuest Capital Management, which formed Mycovia in 2018. “If approved, oteseconazole will be the first FDA-approved therapy for the treatment of this disease. We are proud to be at the forefront of a growing movement in healthcare to focus on undertreated conditions like RVVC, which can negatively impact so many aspects of a woman’s life physically, emotionally and financially.”

Oteseconazole was designed to be highly selective for its pathogenic target, with fewer side effects and improved efficacy over current treatment options, including fluconazole, the current standard of care for vulvovaginal candidiasis (VVC). Oteseconazole’s clinical development plan was comprised of three trials – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries. Both VIOLET studies met their primary and key secondary endpoints. Additionally, results from ultraVIOLET demonstrated oteseconazole’s effectiveness in treating acute episodes of VVC and reinforced its efficacy and safety profile in treating RVVC as compared to fluconazole. Combined Phase 3 data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year.

“RVVC is an area of tremendous unmet need for which there is currently no FDA-approved treatment. Research shows that fluconazole, the standard of care for VVC, is more than 90% effective in treating an acute episode of VVC1, but in studies of patients with RVVC, greater than 50% of RVVC women experience a recurrence following maintenance therapy discontinuation2,” said Thorsten Degenhardt, PhD, Chief Operating Officer of Mycovia. “We believe, if approved, oteseconazole will provide an important treatment option for healthcare professionals and their patients.”

Given oteseconazole’s Qualified Infectious Disease Product (QIDP) and Fast-Track designations, Mycovia anticipates a six-month review following the FDA’s acceptance of the NDA. With this timeline and pending full FDA approval, Mycovia is preparing for a U.S. launch of oteseconazole in early 2022.

About Mycovia Pharmaceuticals

Mycovia Pharmaceuticals is a late-stage emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies. Our lead product candidate, oteseconazole (VT-1161), is a novel, oral therapy for RVVC that is designed with the goal of having greater selectivity, fewer side effects and improved efficacy. While not yet approved by the FDA, oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to support its potential to be 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, S.A.R., China, Macau, S.A.R., China and Taiwan, China, and 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 also recognizes a tremendous potential for its oral fungal inhibitors and a growing need to treat a range of multi-drug resistant fungal pathogens.