Mycovia Pharmaceuticals Announces Completion of Phase 3 Clinical Trial from Partner Jiangsu Hengrui Pharmaceuticals to Evaluate Oteseconazole for the Treatment of Acute Vulvovaginal Candidiasis (VVC) in China | Companies

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DURHAM, NC – (BUSINESS WIRE) – Nov. November 2021–

Mycovia Pharmaceuticals, Inc. (“Mycovia”) announced today that Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui”) has completed its Phase 3 clinical trial of odeseconazole (SHR8008) versus fluconazole in patients with acute vulvovaginal candidiasis ( VVC). The clinical trial, named SHR8008-302, marks a major advance under Mycovia’s exclusive agreement with Hengrui to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan, for the treatment or prevention of a range of fungal diseases, including recurrent vulvovaginal disease candidiasis (RVVC), onychomycosis and invasive fungal infections.

Hengrui started the randomized, double-blind, double-dummy, parallel-group, fluconazole-controlled, multicenter phase 3 study in April 2021 with the primary aim of investigating the efficacy of oleseconazole versus fluconazole in women with acute VVC. The study took place at 27 locations with 320 subjects. The last person finished their last visit on September 30, 2021, and the data will support an NDA in China for odeseconazole.

In addition, enrollment is ongoing for Hengruis randomized, double-blind, double-dummy, parallel-group, fluconazole-controlled, multicenter Phase 3 clinical trial named SHR8008-301. The two primary objectives are to evaluate the effectiveness of oteseconazole in preventing VVC episodes over 50 weeks and to compare the effectiveness of oteseconazole with fluconazole in treating VVC episodes in women with RVVC. The first subject was enrolled in September 2021 and enrollment is expected to be completed in the third quarter of 2022.

RVVC, also known as chronic yeast infection, is a disease other than VVC and is defined as three or more symptomatic acute episodes of yeast infection per year. RVVC affects nearly 138 million women worldwide and 29 million women in China.

“We are excited about the advancement of the Oteseconazole program and will continue to work closely with Mycovia to bring this amazing molecule to tens of millions of women with vulvovaginal candidiasis,” said Lianshan Zhang, senior vice president and president of global R&D, Hengrui. “Based on the data collected from previous odeseconazole studies around the world, we believe it could address a significant unmet medical need in this country.”

“We congratulate Hengrui on achieving these important study milestones evaluating the potential of oteseconazole as a valuable treatment for acute yeast infections and chronic yeast infections,” said Patrick Jordan, CEO of Mycovia and partner at NovaQuest Capital Management. “The burden of disease in China is significant and other treatment options are needed. We are grateful to be able to work together to advance our partnership to meet the unmet needs of millions of women. “

For more information on the Hengrui Phase 3 studies, visit https://clinicaltrials.gov/ under NCT number NCT04956419 for Study SHR8008-302 and NCT05074602 for Study SHR8008-301.

In the United States, the U.S. Food and Drug Administration (FDA) recently accepted Mycovia’s New Drug Application (NDA) for oteseconazole for the treatment of RVVC for review and set a target for the action under the Prescription Drug Users Act (PDUFA) : January 27, 2022. Oteseconazole was previously designated a Qualified Product for Infectious Diseases (QIDP) and Fast-Track by the FDA. With this timeline, and pending full review and FDA approval, Mycovia is preparing to launch Oteseconazole in the US in early 2022.

About Mycovia Pharmaceuticals

Mycovia Pharmaceuticals is a young, emerging biopharmaceutical company dedicated to recognizing and empowering people with unmet medical needs through the development of novel therapies. Our lead product candidate, Oteseconazole (VT-1161), is a novel oral therapy for RVVC that has been developed with the goal of higher selectivity, fewer side effects and improved efficacy. Though not yet FDA approved, Oteseconazole received FDA approval as a qualified infectious disease and fast-track product to demonstrate its potential as the first FDA-approved treatment for RVVC. In 2019, Mycovia licensed Oteseconazol to Hengrui to develop and commercialize Oteseconazol in China, including mainland China, Hong Kong, Macau and Taiwan, and Gedeon Richter Plc., A Hungary-based pharmaceutical company, to market and manufacture Oteseconazol in Europe, Russia, the Commonwealth of Independent States, Latin America and Australia. Mycovia also recognizes tremendous potential for its oral antifungal agents and a growing need for the treatment of a range of multi-drug resistant fungal pathogens. More information is available at www.mycovia.com.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Jiangsu Hengrui Pharmaceuticals Co., Ltd. was founded in 1970 and is a leading biopharmaceutical company based in China with annual net sales of over $ 4.2 billion in 2020. Hengrui is dedicated to promoting healthier living through research with skills in oncology, immunology and anesthesiology, Cardiovascular diseases, metabolic diseases and pain therapy. Hengrui has more than 240 clinical studies ongoing worldwide.

About odeseconazole

Oteseconazole (VT-1161) is a novel oral investigational drug for the treatment of recurrent vulvovaginal candidiasis (RVVC). Oteseconazole was developed with the aim of achieving greater selectivity, fewer side effects and improved efficacy compared to currently available antifungal drugs. Oteseconazole received FDA approval as a qualified infectious disease and fast-track product and, if approved, could be the first FDA-approved treatment for RVVC. Phase 3 clinical trials with odeseconazole have been conducted in 11 countries. Please visit https://www.clinicaltrials.gov for more information.

About recurrent vulvovaginal candidiasis

RVVC is a debilitating, chronic infectious disease that affects 138 million women worldwide each year. RVVC, also known as chronic yeast infection, is a disease distinct from vulvovaginal candidiasis (VVC) and is defined as three or more symptomatic acute episodes of yeast infection per year. Primary symptoms are vaginal itching, burning, irritation, and inflammation. Some women may experience abnormal vaginal discharge and painful intercourse or urination, causing varied, but often severe, discomfort and pain.

About NovaQuest Capital Management

Founded by a team of accomplished industry professionals who began working together in 2000, NovaQuest Capital Management is a leading biopharmaceutical and life sciences investment firm. NovaQuest pioneered an industry PRODUCT FINANCE ™ investment solution that provides high-risk, non-dilutive financing that enables partner companies to advance critical clinical trials, launch new brands, license products, and acquire value-added products or businesses. NovaQuest has invested in numerous biopharmaceutical assets in therapeutic areas with clinical success rates well above the industry average. NovaQuest currently manages more than $ 2.2 billion in capital and is actively investing from the $ 1.2 billion Pharma Opportunities Fund V, evaluating global opportunities with funding needs of $ 30 million to $ 100 million. More information is available at www.novaquest.com.

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CONTACT: Mycovia Pharmaceuticals, Inc.

[email protected]

FleischmannHillard

Elizabeth Comtois, 919-334-3786

[email protected]

KEYWORD: NORTH CAROLINA CHINA MACAU UNITED STATES HONG KONG NORTH AMERICA ASIA-PACIFIC TAIWAN

INDUSTRY KEY: WOMEN’S INFECTIOUS DISEASES FDA BIOTECHNOLOGY CLINICAL STUDIES HEALTH CONSUMERS PHARMACEUTICAL GENERAL HEALTH

SOURCE: Mycovia Pharmaceuticals, Inc.

Copyright Business Wire 2021.

PUB: 11/03/2021 8:30 a.m. / DISC: 11/03/2021 8:32 a.m.

http://www.businesswire.com/news/home/20211103005162/en


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