Hepatera, a Russian biotech company founded in late 2011 with the goal to develop and launch into the Russian market innovative products for treatment of liver diseases, has recently received notification from the Russian Ministry of Health for approval to begin a clinical trial associated with a drug registration submission, and can now proceed with the clinical development of Myrcludex B for treatment of chronic viral hepatitis B in the Russian Federation.
A Skolkovo resident Hepatera has been financed by Maxwell Biotech Venture Fund created with the participation of RVC and is developing an innovative drug candidate for treatment of chronic viral hepatitis B and D in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Gründerfonds (HTGF), one of Europe’s largest venture funds.
Chronic viral hepatitis B (HBV) is one of the serious problems that healthcare systems are faced globally. According to the World Health Organization, the prevalence of HBV (hepatitis B) infection in the world is very high: about 2 billion people are carriers of HBV, of which about 400 million are chronically ill. About 5% of patients with HBV are co-infected with HDV, which increases the severity of disease and hasten the complications, doubling the 5-years mortality rate. So far there are limited options to treat the HDV co-infection.
The idea for Myrcludex B was developed within two renowned research institutions in Europe, the French National Institute of Health and Medical Research (INSERM) and University of Heidelberg in Germany. The lead compound blocks the penetration of Hepatitis B and D viruses into hepatocytes (liver cells) thus creating a reserve for the restoration of liver tissue and preventing disease progression as well as development of complications such as cirrhosis and hepatocellular carcinoma.
“The open randomized clinical trial of the daily use of Myrcludex B compared with entecavir in patients with HBeAg-negative chronic hepatitis B, Phase Ib-IIa” approved by the Russian Ministry of Health will be conducted by Hepatera in specialized clinical centers in major Russian cities: Moscow, Saint-Petersburg, Chelyabinsk and Samara.
Pavel Bogomolov, head of hepatology department of MONIKI named after M.F.Vladimirov, head of the Moscow regional hepatology center, leading hepatologist of Moscow region: “Despite the mass vaccination, about 1.1 million people in this country require treatment of viral hepatitis B and D each year. Unfortunately, the existing standards of care does not give the opportunity to fully address this serious medical and social problem. Given the positive results obtained in previous stages of Myrcludex B development, we have every reason to believe that a clinical trial to be conducted in a number of Russian specialized centers will be successful.”
Alexander Alexandrov, Medical Director – COO at MYR GmbH: “This clinical trial will allow us for the first time to obtain data on the tolerability and potential therapeutic effect of Myrcludex B in patients with viral hepatitis B in need for treatment. This important step in the development of the drug became possible due to the fruitful cooperation with Hepatera and Maxwell Biotech Venture Fund and sets an example of successful cooperation between Russian and European development teams.”
Yan Ryazantsev, Director of Investment and Expertise Department with RVC: “We are always glad when portfolio companies which are created with the participation of RVC meet|pass the most important milestones in their development. Despite the fact that Hepatera was established not long ago, such progress shows properly structured business strategy in the company as well as the high level of competence of its management team. Together with Maxwell Biotech team we are looking forward to the positive results of Myrcludex B studies, which will significantly advance the search for solutions of such an important health issue as chronic hepatitis.”