MYR GmbH and it`s development partner Hepatera LLC today announced that the European Medicines Agency (EMA) granted “PRIME eligibility” for Myrcudex B, a first in class entry inhibitor for Hepatitis Delta (D) virus.
«It is very encouraging that the European regulator recognizes the importance the unmet medical problem in hepatitis delta and is willing to support the development of Myrcludex B», said Heiner Wedemeyer, MD, 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 2b 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, PhD, DZIF-Professor for Translational Virology at the University of Heidelberg, inventor of the technology and collaboration partner of MYR GmbH and Hepatera LLC.
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
About Myrcludex B
Myrcludex B is a first in class entry inhibitor for treatment of chronic hepatitis B and D. The drug has shown promising efficacy in Phase 2a trials. Recruitment for Phase 2b program in HDV is completed.