ROCHE LAUNCHES TRIAL OF POLYMERASE INHIBITOR IN HEPATITIS C

Roche has announced the initiation of the first Phase II study to evaluate R1626, an investigational polymerase inhibitor, for the treatment of chronic hepatitis C. The drug has been granted fast-track designation by the FDA, a program designed to facilitate the development and to expedite the review of new drugs with the potential to help treat serious or life-threatening conditions.

R1626, which has been shown to have a strong antiviral effect, uses a different mechanism of action from the current standard hepatitis C treatment. 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. While patients with genotype 1 virus in clinical trials with Roche's currently available hepatitis C therapies, Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), had an approximate 50 percent chance of achieving a sustained virologic response (SVR). A strong medical need remains for new therapies to improve these response rates.

The Phase II trial will evaluate the safety and antiviral effect of R1626 in combination with Pegasys and Copegus. The study is an ongoing multicenter trial that is enrolling patients with genotype 1 chronic hepatitis C who have not previously received treatment. Patients are randomized into four treatment groups: R1626 1,500 mg twice a day plus Pegasys 180 micrograms; R1626 3,000 mg twice a day plus Pegasys 180 micrograms; R1626 1,500 mg twice a day plus Pegasys 180 micrograms plus Copegus 1,000-1,200 mg daily; and Pegasys 180 micrograms plus Copegus 1,000-1,200 mg.

Following the first four weeks of treatment, all patients will receive Pegasys 180 micrograms subcutaneously every week with Copegus 1,000-1,200 mg daily for another 44 weeks, for a total treatment duration of 48 weeks. The objectives of the study are to evaluate the four-week safety and antiviral effect of combining R1626 with Pegasys and/or Copegus.