Hepatera, a Skolkovo resident company, completes enrollment of Phase IIa clinical trial of Myrcludex B, a novel entry inhibitor for treatment of chronic HBV infection

A resident of the Russian Innovation Center Skolkovo 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.

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 and 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.

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.

The 48 patients have been enrolled in 8 specialized clinical centers in Russia. Preliminary results are expected in June 2014 and will be presented at international specialized conferences.

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.

Kirill Kaem, Executive Director of the BioMedical Cluster of Skolkovo Foundation: “Hepatera Company has been Skolkovo’s resident since November 2011 and its proposed approaches have a very high potential in treatment of chronic viral hepatitis. The project itself is an attractive example of technology transfer. The significant part of research work during clinical trials will be done in Russia, which is one of the key factors for Skolkovo Foundation.”

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”.

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”.

About Hepatera

"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 originated from the research at the University Hospital Heidelberg, and is being developed in the framework of international cooperation with the biotechnology company MYR, GmbH (Germany).

About MYR GmbH

MYR GmbH is a biotechnology company developing Myrcludex B, a drug for the treatment of chronic hepatitis B and D virus 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. 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 relies on an experienced international team of managers and financial and industry experts and has offices in Moscow and Boston. To date, MBVF has invested in 9 companies: OncoMax (oncology), NeuroMax (neuroscience), MetaMax (oncology & metabolic diseases), Infectex (infectious diseases), CardioNova (cardiovascular diseases), Hepatera (hepatology), Osteros Biomedica (cancer induced bone diseases), Eleventa (inflammatory respiratory diseases) and Photonics (novel lasers for medicine and dentistry). Products in these companies originated either from Russian scientists or were licensed for commercialization in Russia from international biotech, pharmaceutical and medical device companies.

About Skolkovo Foundation

The Skolkovo Foundation is a non-profit organization founded in September 2010 by the Russian government with an objective to accelerate transformation of Russia from a resource-intensive to an innovation-based economy. To achieve this objective the Foundation is overseeing the creation of the Skolkovo Innovation Center composed of companies and startups, developing innovative technologies (currently numbering over 1000), a Technopark, the Skolkovo Institute of Technology (Skoltech), a new graduate research University established in collaboration with the Massachusetts Institute of Technology, and Skolkovo city, located near Moscow. Together these entities will establish a vibrant ecosystem of technology innovation and entrepreneurship. 28 world’s most successful corporations, including Boeing, Cisco Systems, EADS, GE, Johnson & Johnson, IBM, Intel, Microsoft, Siemens, Nokia, Samsung etc. have already recognized the opportunity Skolkovo presents having signed R&D partnership agreements with the Foundation. For more information: http://www.sk.ru/en

Contacts:

Maxwell Biotech Group

Alexey Eliseev, Managing Director

Office: +1 (857) 2847220 ext. 153

e-mail: aeliseev@maxwellbiotech.com

Hepatera

Oksana Markova, CEO

Office: +7 (495) 4116992

e-mail: markova@hepatera.ru

MYR GmbH:

Dr. med. Alexander Alexandrov, Medical Director / COO

Office: +7 (495) 4116992