Hepatera Ltd and its development partner MYR GmbH announced today the results of clinical trials investigating Myrcludex B in patients with chronic hepatitis B (HBV) and delta (HDV). The results suggest that Myrcludex B may become an option for treating hepatitis delta. With details to be presented at the AASLD meeting in Boston in November 2014, the trials also indicate positive results for the treatment of HBV infection.
A Phase 2a trial investigating effects of several Myrcludex B doses in 40 patients with chronic HBV infection showed that the drug was very well tolerated. A dose-dependent effect on HBV DNA was observed: >1 log10 HBV DNA decline at week 12 occurred in 6/8 (75%) patients receiving 10mg Myrcludex B while this occurred less often in the remaining dose groups (7/40; 17%). The HBV DNA response was maintained in 10mg patients through week 24.
In a Phase 2a trial in chronic HDV infection with 24 patients, Myrcludex B was investigated as monotherapy vs combination with pegylated interferon alpha for 24 weeks; a control arm received pegylated interferon alpha alone. Myrcludex B was very well tolerated both as monotherapy and in combination with interferon. Myrcludex B has shown strong single agent efficacy against HDV. 6 out of evaluable 7 patients experienced >1 log10 HDV RNA decline at week 24; 2 patients became HDV RNA negative and in further 2 the values dropped below the limit of quantification. In the combination arm, all patients had HDV RNA decline and 5 were HDV RNA negative at week 24. Importantly, ALT normalized in 4 Myrcludex B monotherapy patients at week 24.
«These results indicate biological activity of a non-interferon drug for the treatment of HDV infection which can represent a major breakthrough in the management of this most severe form of viral hepatitis», said Heiner Wedemeyer, Professor of Hannover Medical School, Germany, and Chairman of MYR`s clinical advisory board.
With about 350 million infected, chronic hepatitis B is one of the major problems facing healthcare systems globally. A significant unfulfilled demand for new therapies exists due to the lack of curative treatment options. Hepatitis delta is the most severe form of viral hepatitis affecting 15-20 million individuals worldwide. No treatment options are available for the majority of hepatitis delta patients. Myrcludex B is blocking NTCP, the receptor essential for both HBV and HDV, and thus inhibits the new infection of liver cells.
Prof. Stephan Urban (University Hospital Heidelberg), originator of the technology: «Myrcludex B becomes an option for controlling hepatitis delta virus infection. Moreover, more and more evidence is evolving that inhibition of entry and intrahepatic spread of HBV and HDV may play an essential role of future curative regimes».
Hepatera Ltd is a private Russian biotech company funded by Maxwell Biotech Venture Fund. Hepatera develops novel 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 delta. Myrcludex B originated from the research at the University Hospital in Heidelberg, Germany, and is being developed in collaboration with the biotechnology company MYR GmbH, a German Biotech belonging to High-Tech Gruenderfonds portfolio, which is holding international product rights.
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