Clinical trials for chronic B-type viral hepatitis get ‘green light’
25 Sep '12
Hepatera, a Russian biotech company set up in late 2011 to develop and commercialize drugs to fight liver disorders, has received approval by the Russian Ministry of Healthcare for Ib-IIa phase clinical trials of its new drug candidate, Myrcludex B, in patients with chronic B-type viral hepatitis, the official Russian Venture Company (RVC) website reports.
The start-up has received investment for this work from Maxwell Biotech, a Russian VC fund co-established by Russian Venture Company. RVC is the Russian fund of funds and one of this country’s so-called development institutions (alongside Rusnano, Skolkovo, VEB Bank and some others).
Hepatera reportedly pushes this Myrcludex B project in collaboration with MYR GmbH, a German biotech firm financed by one of Western Europe’s largest VC funds, High-Tech Gründerfonds.
Under plans, Hepatera will conduct the clinical trials at specialized clinical centers in Moscow, St. Petersburg, Chelyabinsk (Urals) and Samara (Lower Volga).
The B-type viral hepatitis incidence is high in the world; about two billion people are believed to be carriers of the virus, and as many as 350 million of those are chronic patients. An estimated 5% of those with chronic B-type viral hepatitis also have the D-type hepatitis virus. This sort of cross-infection causes much faster and sometimes irreversible liver injuries.
According to Pavel Bogomolov, the chief hepatologist of the Moscow Regional Ministry of Healthcare, “…about 1.1 million Russian citizens need yearly B- and D-type viral hepatitis therapies.”
Myrcludex B is said to be of peptide origin and works by blocking the B- and D-type hepatitis viruses’ penetration into healthy hepatocytes (liver cells). This gives the liver some ‘room’ to restore its tissue and prevents deterioration and possible complications like cirrhosis and hepatocellular carcinoma.
This approach gives the researchers hope that a limited therapy will be enough to cure the disease. Antiviral nucleotide/nucleoside analogs prescribed by physicians today typically presuppose recurrent lifelong therapies.