DURHAM, N.C.--(BUSINESS WIRE)--Mycovia Pharmaceuticals, Inc. (“Mycovia”) today announced that Chief Executive Officer Patrick Jordan will participate in a spotlight presentation at BIO-Europe 2019 being held November 11-13 in Hamburg, Germany. The panel, titled “Evolving priorities in women’s health,” will generate conversation about the future of women’s health as an important focus for research and development, current areas of unmet need and growing opportunities within the market. Mycovia’s lead product, VT-1161, is an oral antifungal product currently in global Phase 3 clinical trials for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC), a debilitating, chronic infectious condition that affects nearly 138 million women worldwide each year. There are currently no FDA-approved therapies for RVVC.
Historically, diseases affecting only women have been overshadowed by conditions with higher mortality and morbidity rates. However, there is a growing focus on those conditions that have a serious impact on women’s lives both physically and emotionally. The session, to be held on November 11 at 1:30 p.m. CET, will discuss financing routes for companies driving innovation in the category and the future of women’s health as an R&D area of focus and growing market. The panel will be moderated by Lucie Ellis, editor of In Vivo, and Mr. Jordan will be joined by other industry executives who are driving innovation in women’s health.
“At Mycovia, we are committed to advancing women’s health and are proud to be at the forefront of this movement,” says Mr. Jordan. “RVVC affects the daily lives of millions of women, and while not life-threatening, the physical and emotion impact of the disease is significant. Through having this important conversation at industry events like BIO-Europe, we will continue to drive partnerships and innovation that can address these and other significant unmet health needs of women.”
VT-1161 has received FDA Qualified Infectious Disease Product (QIDP) and Fast-Track designations and has the potential to become the first FDA-approved treatment for RVVC. VT-1161 is designed to be highly selective, with fewer side effects and improved efficacy over current treatment options. Data from Mycovia’s Phase 2b study in RVVC showed VT-1161 to have a strong safety and efficacy profile in patients over the 48-week study period.
As part of Mycovia’s focus on building its global commercial capabilities in anticipation of launching VT-1161 in the U.S. in 2021, the company recently signed global exclusive licensing agreements to expand access to VT-1161 in other parts of the world. In October 2019, Mycovia licensed VT-1161 to Gedeon Richter, a Hungary-based leader in women’s health that will commercialize and manufacture the drug in Europe, Latin America, Australia, Russia and the Commonwealth of Independent States. In June 2019, Mycovia licensed VT-1161 to Jiangsu Hengrui Medicine, the largest pharmaceutical company in China and one of the largest in the world, to develop and commercialize VT-1161 in China, including mainland China, Hong Kong, Macau and Taiwan.
About Mycovia Pharmaceuticals
Mycovia Pharmaceuticals has a passion for developing breakthrough therapies in areas of unmet medical need, with an initial focus in women’s health. Our lead product candidate, VT-1161, is a novel, oral therapy for RVVC that is designed to have greater selectivity, fewer side effects and improved efficacy than current treatment options. VT-1161 received FDA Qualified Infectious Disease Product and Fast-Track designations to support its potential as the first FDA-approved treatment for RVVC. Mycovia also recognizes that there is tremendous potential for its oral fungal inhibitors to treat a range of multi-drug resistant fungal pathogens. For more information, please visit www.mycovia.com.
About Recurrent Vulvovaginal Candidiasis
RVVC is a debilitating, chronic infectious condition that affects millions 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.
