MYR Pharmaceuticals receives conditional marketing authorisation by European Commission for HEPCLUDEX

MYR Pharmaceuticals, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D, is pleased to announce that the European Commission (EC) has granted the Conditional Marketing Authorization (CMA) for their lead compound HEPCLUDEX.

HEPCLUDEX has been approved as the first treatment option for adult patients with chronic hepatitis delta virus infection and compensated liver disease in Europe.

The drug was originally developed by scientists at the University of Heidelberg (Germany) and INSERM (France). Prof. Stephan Urban, co-inventor of Hepcludex, DZIF-Professor for Translational Virology at the University of Heidelberg and lead scientist in the continuing research program between MYR Pharmaceuticals and Heidelberg University expresses his enthusiasm:” Today’s approval marks a great achievement for patients suffering from the most severe form of viral hepatitis without any specific treatment option until today.  I am excited that after more than 20 years of scientific and clinical research, the entry inhibitor Myrcludex B, now HEPCLUDEX®, becomes accessible to patients and will significantly improve their lives.”

The CMA is based on the results from two Phase II studies (MYR202 and MYR203), which demonstrated good tolerability and safety as well as significant reduction of viremia and improvement of liver function during treatment with HEPCLUDEX®.

Currently, MYR Pharmaceuticals has one Phase III HDV study ongoing evaluating the long-term treatment of HEPCLUDEX and one Phase II HDV study investigating the combination of HEPCLUDEX® with pegylated interferon.

HEPCLUDEX represents the most clinically advanced novel approach for the treatment of hepatitis D, and is currently in a Phase 3 study in the indication of chronic HDV. The drug inhibits the HBV/HDV receptor NTCP on the hepatocyte surface and prevents the infection of regenerating cells and viral spreading within the liver.

HEPCLUDEX has received Orphan Drug Designation for treatment of HDV infection from the European Medicines Agency (EMA) and from the U.S. Food & Drug Administration (FDA). In addition, the EMA has granted PRIority MEdicines (PRIME) scheme eligibility. In parallel the FDA has granted Breakthrough Therapy designation – a process designed to expedite the development and review of drugs which may demonstrate substantial improvements on a clinically significant endpoint.