First Clinical Trials Successfully Completed on Potent New Hepatitis C Drug

The first clinical trials on a new investigational drug being developed to treat infections caused by Hepatitis C virus have been successfully completed.

Completion of the initial phase (phase 1a) of trials of INX-189, discovered and first prepared by researchers at Cardiff University's Welsh School of Pharmacy in 2008, means the chances of it becoming an approved medicine have significantly improved.

Approximately 170 million people worldwide are affected with hepatitis C, which can lead to liver cancer, cirrhosis and death. It is the leading cause of liver transplantation in western countries. The current treatment involves two drugs ribavirin and interferon, which has to be given as an injection. Side effects are often severe and lead to patients failing to complete the treatment.

Professor Chris McGuigan of the Welsh School of Pharmacy, academic lead on the project, says, "This is still a very early stage of the trials process but none the less a significant development. Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg. The efficiency of drug release in this study has also confirmed that one single dose a day is most likely enough in treating the virus. We believe that INX-189 offers the possibility of more potency against hepatitis, more rapid action in the liver, and fewer side effects than existing treatments."

In 2008, laboratory tests showed INX-189 killed 90 per cent of the virus at very low (nanomolar) concentration, making it the most potent compound of its kind developed to date.

U.S. pharmaceutical company Inhibitex, which owns the licence to INX-189 and has been working with the Cardiff team, has announced it is looking forward to a second trial (phase 1b), which would evaluate the compound's effectiveness in hepatitis C patients.

Cardiff University and Inhibitex filed a patent on INX-189 earlier this year. It has been cleared for human clinical trials by the Food and Drug Administration in the U.S.