European Commission approves first drug for hepatitis D

pharmafile | August 6, 2020 | News story | Business Services EC, hepatitis C, hepatitis D 

The European Commission has approved Heplcudex (bulvirtide) as the first hepatitis D drug.

It was jointly developed by researchers at the Medical Faculty of Heidelberg and the German Center for Infection Research and is the first entry inhibitor for the treatment of hepatitis D and B viruses from entering liver cells.

Hepcludex’s mechanism of action is based on a ‘lock and key’ principle according to the researchers. The virus exclusively replicates in the liver as they require the bile acid transporter NTCP to do so. They use this lock to enter the cell. Hepcludex blocks this lock, acting like a broken key that is stuck in the lock. It also works after an infection has occurred and the virus has already entered the cell.

The 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. A Phase 3 trial is currently under way to investigate the long-term effects of the treatment.

Prof. Hans-Georg Kräusslich, spokesman of the Center of Infectious Disease Research at the UKHD and Chairman of the German Center for Infection Research said: “We are very pleased about this success which is based on decades of virology research in Heidelberg. This drug was developed in close collaboration between partners in science, public funders and a biotech company and is therefore an epitome of successful translation of laboratory results into clinical application.”

Conor Kavanagh

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