MYR Pharma GmbH, a German clinical stage biotech company, announced the completion of its MYR 202 clinical trial, a phase 2b study investigating Myrcludex B in chronic hepatitis Delta (HDV), the most severe form of viral hepatitis that currently has no satisfactory treatment options. A total of 120 subjects were enrolled into MYR 202 in 20 centers in Russia and Germany, which makes it the world's largest HDV clinical study.
The results of the study will be presented at the General Session of the upcoming International Liver Congress, an annual meeting of the European Association for the Study of the Liver (EASL) in Paris, France on April 12, 2018.
"The positive results of the active therapy phase of this study were already presented at the AASLD meeting in Washington, DC in October 2017," said Alexander Alexandrov, MD, chief medical officer of MYR Pharma. "The follow-up phase of this study is now completed. This is a very important milestone in the development of Myrcludex B under the PRIME scheme in Europe," he added.
"We appreciate that the EASL annual meeting organizers recognize the significance of the HDV medical problem and the importance of the results of this so far largest study with a novel compound in hepatitis Delta", said Heiner Wedemeyer, MD, Professor at Essen University Hospital and Chairman of MYR Pharma's Clinical Advisory Board.
Myrcludex B is a first-in-class entry inhibitor for the treatment of chronic hepatitis B (HBV) and its co-infection hepatitis Delta. 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 drug has received Orphan Designation for treatment of HDV infection from the EMA and FDA, and PRIME scheme eligibility from the EMA.
MYR Pharma GmbH is a German clinical stage biotechnology company focused on the development of drugs for the treatment of chronic hepatitis B and Delta virus infections.