MOSCOW, November 28, 2017 /PRNewswire/ —
Hepatera LLC and it`s development partner MYR GmbH today announced positive interim results in MYR 202 clinical trial, a Phase 2b study investigating Myrcudex B in chronic hepatitis delta infection. 120 subjects have been enrolled into this study in 15 centers in Russia and Germany and have completed active treatment phase.
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After 24 weeks of treatment, Myrcludex demonstrated excellent safety profile with no drug-related SAEs or treatment discontinuations due to the study drug. Patient`s adherence to the treatment was very high. The primary endpoint, HDV RNA decline >2log10 or negativation was met for all doses of Myrcludex B. In the 10mg treatment group, the endpoint was achieved by 76.6% of patients, vs 3.3% in control arm. Median HDV RNA decline was 2.7log10 in 10mg arm, vs. 0.18log10 in control arm.
Myrcludex treatment was associated with marked biochemical response in all Myrcludex arms, but not in the control arm. At week 24, 40% of patients in 10mg arm achieved ALT normalization (6.6% in control arm). Median ALT levels in 10mg and control arm were 43 U/L and 76 U/L, respectively. All differences between Myrcludex and control arm were highly statistically significant.
Importantly, trends to decrease in liver stiffness and a decrease of intrahepatic HDV RNA levels were observed in Myrcludex arms.
The interim results of the trial were presented at the recent American Association for the Study of Liver Diseases Conference by Prof. Heiner Wedemeyer (Hannover Medical School, Germany).
«This was one of the world-largest controlled treatment trial for chronic hepatitis delta so far», said Heiner Wedemeyer, “Patients with advanced disease (50% cirrhotics), and no other therapeutic options were included into the study. These results are very promising. The study could be a major milestone on the way to create effective treatments for this desperate patient population”.
About Myrcludex B
Myrcludex B is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D 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. Myrcludex B has shown good safety profile and antiviral activity in animal models and in proof-of-concept clinical trials, has received Orphan Designation for treatment of HDV infection from EMA and FDA, and PRIME scheme eligibility from EMA.
Hepatera LLC 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 is being developed in the framework of international cooperation with the biotechnology company MYR, GmbH (Germany).
About MYR GmbH
MYR GmbH is a clinical stage biotechnology company focused on drugs for the treatment of chronic hepatitis B and D virus infections.
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 portfolio companies have nine innovative clinical stage drug candidates in development.
SOURCE Maxwell Biotech Venture Fund