Hepcludex: First drug for hepatitis D has been approved
Over the course of 25 years of research, Stephan Urban and his team developed Hepcludex, the first drug for Hepatitis D.
Professor Stephan Urban and his team developed the first drug for hepatitis D at the Heidelberg University Hospital. So far, there has been no curative treatment – the number of chronically infected patients is high. The drug, which blocks the entry of the hepatitis B and hepatitis D virus into the liver cell, was approved by the European Commission on 31 July 2020 as a drug with the trade name Hepcludex, initially for hepatitis D. The potential uses for hepatitis B are still being investigated.
„The development of the drug is an epitome of successful translation of laboratory results into clinical application.“
Background
25 years ago, Stephan Urban discovered the mechanism by which the hepatitis B virus docks to the liver cell. The peptide, which is crucial for the entry of the virus into the cell, was developed over many years into a drug that will initially benefit hepatitis D patients. Hepatitis D infections only occur as an HBV co-infection and lead to liver cirrhosis and liver cancer even more quickly than is the case with HBV infection alone. About 25 million people in the world are suffering from a hepatitis D infection.
Development
Hepcludex (active ingredient name Bulevirtide) blocks the bile salt transporter NTCP (yellow), which is used by the virions (orange) as entry ports into the liver cells.
Since his appointment as a DZIF professor in 2014, Stephan Urban (Heidelberg University Hospital) has focused on developing a drug based on the blocking peptide he discovered: Myrcludex B. The cooperation with another DZIF team began with the necessary tests in the animal laboratory. Maura Dandri and her team at the University Medical Center Hamburg-Eppendorf succeeded in growing human liver cells in mice. The peptide was also able to prevent infection in mice. The way was paved for clinical trials.
Several phase I and II clinical trials showed that humans tolerate the agent well and that it efficiently prevents the replication of hepatitis B and D viruses. Phase II studies were conducted parallel to the DZIF-funded phase I trial by the licensee and DZIF-contract partner MYR Pharmaceuticals GmbH in Russia. Myrcludex was approved in Russia and the former Soviet Union at the end of 2019. A Phase III study is currently being carried out to investigate the long-term effect of Hepcludex, amongst other things. The scientists also want to test whether the combination of Hepcludex with an immunomodulator can help hepatitis B patients without HDV co-infection.
Partners
- Heidelberg University Hospital
- INSERM
- MYR Pharmaceuticals GmbH (Gilead Sciences, Inc.)
- DZIF