MOSCOW, Russia I March 6, 2014 I A group of 48 patients infected with the hepatitis B virus (HBV) have been enrolled in the phase IIa clinical trial of Myrcludex B by Russian biotech company Hepatera Ltd. Hepatera is financed by Maxwell Biotech Venture Fund, set up with the participation of RVC – Russia’s government fund of venture capital funds. Hepatera was founded in 2011 with the goal of developing and launching innovative therapeutics for treatment of liver diseases into the Russian market.

Hepatera is developing an innovative drug candidate – Myrcludex B – for treatment of chronic viral hepatitis B and D in close cooperation with the German biotech company MYR GmbH, a portfolio company of High-Tech Gruenderfonds (HTGF), one of Europe’s largest venture funds.

The objectives of the ongoing Phase IIa clinical trial are to study safety and tolerability, as well as efficacy of several dose levels of Myrcludex B in comparison to standard therapy (nucleoside analogues). One specific aim is to study efficacy parameters not influenced by the standard therapy in the majority of cases.

Preliminary results are expected in June 2014 and will be presented at international specialized conferences.

Dr. Alexander Alexandrov (Medical Director, MYR GmbH): “Introduction of potentially curative therapies for chronic HBV infection is awaited by the patients for a long time. We look forward to the evaluation of the results of this study which might become a significant step on the path of creating a new tool in treatment of this important disease”.

Chronic viral hepatitis B (CHB) is one of the major problems facing healthcare systems globally. According to the World Health Organization, the prevalence of hepatitis B virus infection (HBV) worldwide is very high with about 350 million of them chronically infected. The market for chronic hepatitis B therapy is constantly growing, with significant unfulfilled demand for new therapies due to the lack of curative treatment options.

Prof. Stephan Urban (University Hospital Heidelberg), originator of the technology: “The enrollment of all planned patients into this trial is a very significant milestone for the drug; the success of the molecule can change treatment standards of chronic viral hepatitis B”.

SOURCE: Hepatera