Roche’s HCV Drug Enters Phase II

Roche has initiated the first Phase II study to evaluate R1626, an investigational polymerase inhibitor, for the treatment of chronic hepatitis C. The drug has also been granted Fast Track designation by the FDA.

R1626 uses a different mechanism of action from the current standard HCV treatment and has been shown to have a strong antiviral effect. In a Phase I study, the drug achieved significant reductions in viral levels in chronic hepatitis C patients infected with genotype 1, the most difficult to treat form of the virus. 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 sustained virologic response (SVR). There is still a strong medical for new therapies to improve these response rates. The trial will evaluate the safety and antiviral effect of R1626 in combination with Pegasys and Copegus.