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.
Chronic viral hepatitis B 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. Hepatitis delta is the most severe form of viral hepatitis affecting 15-20 million individuals worldwide. Apart from interferons, which are effective in only a minor subset of HDV patients, no treatment options are available for hepatitis delta. Myrcludex B is blocking NTCP, the receptor essential for both HBV and HDV, and thus inhibits the new infection of liver cells.
Dr. Alexander Alexandrov, CMO of MYR GmbH, said: “Myrcludex B has demonstrated the potential to become an option for controlling hepatitis delta. Moreover, more and more evidence is evolving that the inhibition of intrahepatic spread of HBV may become part of future curative regimes”.
About MYR GmbH
MYR GmbH is a German biotechnology company developing Myrcludex B, a drug for the treatment of chronic hepatitis B and D virus infections. MYR GmbH belongs to portfolio of HTGF, one of Europe largest venture funds. 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. 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 nine therapeutic and medical device companies. These companies are developing products originating either from Russian research groups or licensed for commercialization in Russia from international biotech, pharmaceutical and medical device companies.
About High-Tech Gruenderfonds
High-Tech Gründerfonds invests venture capital in young technology companies with promising research results and strong potential to enable then to transform innovative ideas into entrepreneurial success. Seed financing helps startups take their R&D projects to the prototype, “proof-of-concept” or market launch phases. The fund participates with an initial €500,000; a total of up to €2 million per enterprise are available. The public-private partnership investors include the German Federal Ministry of Economics and Technology, the KfW Banking Group alongside the 18 corporate investors. High-Tech Gründerfonds manages a total investment portfolio of around €576 million (€272m Fonds I and €304m Fonds II).
Maxwell Biotech Group
Alexey Eliseev, Managing Director
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Dr. med. Alexander Alexandrov, Medical Director / COO