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news.Roche has initiated a phase II study to evaluate R1626, an investigational polymerase, as a therapy to be used in patients with hepatitis C.
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The drug has also been granted fast track designation by the Food and Drug Administration. Fast track is a program designed to facilitate the development of new drugs with the potential to help treat serious or life-threatening conditions.
In a phase I study, the drug achieved significant reductions in viral levels in hepatitis C patients infected with genotype 1, the most difficult to treat form of the virus. While patients with genotype 1 virus in clinical trials with Roche’s currently-available hepatitis C therapies, Pegasys and Copegus, had an approximate 50% chance of achieving a virologic response.
The trial will evaluate the safety and antiviral effect of R1626 in combination with Pegaysys and Copegus.
“A product that could potentially improve treatment success rates, particularly for the hardest-to-treat forms of the virus, is much needed,” said Dr Paul Pockros, Head of the Division of Gastroenterology/Hepatology at The Scripps Clinic.