Myrcludex B eligible for EMA PRIME scheme

The European Medicines Agency has granted "PRIME eligibility" for Myrcludex B, a first in class entry inhibitor for hepatitis Delta (D) virus, under development by Germany biotech firm MYT GmbH and its partner Hepatera, a Russian drugmaker.

"It is very encouraging that the European regulator recognizes the importance of the unmet medical problem in hepatitis delta and is willing to support the development of Myrcludex B," said Heiner Wedemeyer, Professor at Hannover Medical School and chairman of MYR's clinical advisory board. "The affected patients are in urgent need of new medications and we are looking forward to the upcoming results of the Phase IIb program with this innovative drug."

"The combined efforts of academic research, public funding and small biotech development and venture activities allowed the clinical development of a completely new drug with a novel mode of action on both Hepatitis B and D virus. The enhanced dialog with EMA will now strongly facilitate further joint effort to bring Myrcludex B to the HDV/HBV co-infected patients in need as fast as possible," commented Stephan Urban, DZIF-Professor for Translational Virology at the University of Heidelberg, inventor of the technology and collaboration partner of MYR and Hepatera.