Hepatera LLC and it`s development partner MYR GmbH today announced the initiation of MYR 202, a Phase 2b open label, randomized clinical trial to evaluate efficacy and safety of Myrcludex B in combination with tenofovir in chronically HBV/HDV сo-infected patients. 120 subjects will be enrolled in 20 centers in Russia and Germany.
We are looking forward to further investigate this novel drug for treatment of the most severe viral hepatitis,” said Heiner Wedemeyer, MD, Professor at Hannover Medical School and Chairman of MYR`s Clinical Advisory Board. “Myrcludex B has shown biological activity in the previuos trials and has the potential to become a new option for these difficult-to-treat patients.
We have discussed the study design with the European and US regulators and hope that the results of the study will build a fundament for a pivotal trial in HDV infection,” said Dr. Alexander Alexandrov (Medical Director, MYR GmbH). “In the same time, the study will provide valuable information of the effect of combination therapy on the underlying HBV infection.
About Myrcludex B
Myrcludex B is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of the healthy cells and viral spreading within the liver. Myrcludex B has shown good safety profile and antiviral activity in animal models and in proof-of-concept clinical trials, and has received Orphan Designation for treatment of HDV infection from EMA and FDA.
"Hepatera" is a private biotech company. The main activity of the company is the development of safe and effective drugs for the treatment of liver diseases for the Russian market. The company’s first product, Myrcludex B, is aimed at the treatment of chronic hepatitis B and D. Myrcludex B is being developed in the framework of international cooperation with the biotechnology company MYR, GmbH (Germany).
About MYR GmbH
MYR GmbH is a clinical stage biotechnology company focused on drugs for the treatment of chronic hepatitis B and D virus infections. The company was founded in 2010 and is based in Burgwedel, Germany.
About Maxwell Biotech Venture Fund
Maxwell Biotech Venture Fund (MBVF) is the first Russian venture fund fully dedicated to investments in the life sciences sector. The fund has been created with the participation of the Russian Venture Company (RVC). MBVF portfolio companies have nine innovative clinical stage drug candidates in development; four thereof are in Phase 2.
Yana Delovery, Program Director
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Dr. med. Alexander Alexandrov, Medical Director / COO
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