Hepatera, a Russian biotech company and part of Maxwell Biotech Venture Fund’s portfolio, has announced today the inclusion of the first three patients with chronic hepatitis B in the clinical trial phase Ib-IIa of Myrcludex B. Hepatera was founded in 2011 and is focused on the development of innovative therapeutics for the treatment of liver diseases. The study is being conducted in major Russian specialized clinical centers and its results are expected in the end of 2013.
Hepatera is a resident of the Skolkovo Biomedical Cluster and has been financed by Maxwell Biotech Venture Fund. Myrcludex B, an innovative drug candidate for the treatment of chronic viral hepatitis B and D, is developed in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Gruenderfonds (HTGF), one of Europe’s largest venture funds.
Despite the widespread introduction of vaccination, chronic hepatitis B remains an unsolved health problem. According to the WHO close to 2 billion people in the world are carriers of HBV, of which about 400 million are chronically ill. Every year approximately 50 million people get infected with HBV and almost 2 million people die from liver conditions caused by this infection. Co-infection with HDV which is diagnosed in about 5% of cases increases the severity of the disease doubling the frequency of complications and mortality rate, compared to monoinfection. To date there are limited options to treat the HDV co-infection.
“It is very important for us that we take part in such a large international project and have the opportunity to be the first center to evaluate the effectiveness of the Myrcludex in patients. We hope that the positive results of this clinical trial will allow the company to continue the development of the drug, which offers a new approach to the treatment of patients with hepatitis B, and will be able to significantly improve and simplify the existing treatment regimen,” said Elena Volchkova, consultant for “Infectious Clinical Hospital a”- 2″ of the Moscow Department of Health, Doctor of Medical Science, Head of the Department of Infectious Diseases of the Sechenov First Moscow State University, principal investigator.
“We are excited to see that Myrcludex has now moved into the clinical study in patients who might benefit from the treatment. In this study we have a particular emphasis on safety, but also looking at HBsAg levels which remain unaffected by current standard treatment regimens in the majority of patients. With the HBV receptor identified now, we hope that the results will boost the field and deliver a milestone in combating this important disease,” said Alexander Alexandrov, Chief Scientific Officer at MYR GmbH.