The European Medicines Agency (EMA) has granted “PRIME eligibility” to Myrcludex B, and will provide priority support for its further drug development. The hepatitis B and D virus entry inhibitor was developed by DZIF scientists at the Heidelberg University Hospital.
PRIME is short for “Priority Medicines”, a scheme launched by the European Medicines Agency (EMA) to provide enhanced support for developing medicines that are needed particularly urgently. EMA considers Myrcludex B to be an agent worth supporting with this program. Drugs for chronic hepatitis D (Delta) are urgently needed: out of 350 million people suffering from chronic hepatitis B infections, approximately 25 million are also carriers of the hepatitis D virus. This co-infection is the most severe form of viral hepatitis for which no specific treatment exists to date.
DZIF Professor Stephan Urban and his research team developed Myrcludex B, and with this an agent now exists that specifically inhibits hepatitis B and D virus liver cell entry. In two clinical trials, the scientists have already demonstrated that the agent is very well tolerated by humans and efficiently inhibits the replication of both hepatitis B and D viruses.
Prof Stephan Urban who discovered the agent and deciphered its mode of action is delighted, “The EMA quality seal and the accompanying dialogue this provides for the further drug development steps will facilitate the process into the approval stage and enable the agent to reach patients earlier.” Urban now heads the further development together with MYR GmbH and Hepatera LLC partners. “Myrcludex B was the only one out of eight applications from the field of infection research that was granted PRIME eligibility in the last approval process,” Urban adds.
Myrcludex B is an example of very successful translational research conducted at the DZIF. The clinical development of the agent, which has a completely new mode of action, was conducted in close collaboration between science, public funding and smaller biotech companies.