Roche, InterMune Initiate Phase 2b Chronic Hepatitis C Trial

Roche and InterMune have announced dosing of first patient in a phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS (pegylated interferon alfa-2a) and COPEGUS (ribavirin).

The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 will participate.

RG7227/ITMN-191 is being developed in partnership by Roche and InterMune. Initiation of the phase 2b trial triggered a $20m event payment from Roche to InterMune, under the companies’ collaboration agreement.

Frank Duff, head of clinical development for Virology at Roche, said: This trial represents an important step forward in the development of this oral direct-acting antiviral (DAA), and builds on the encouraging clinical safety and efficacy data generated to date.

Dan Welch, chairman, chief executive officer and president of InterMune, said: We are very pleased to announce with our colleagues, Roche, the start of the global Phase 2b program of RG7227/ ITMN-191 in treatment-naive HCV patients. This study will significantly expand the clinical efficacy and safety database for RG7227/ ITMN-191, and in the first quarter of next year provide our first look at the rapid virologic response (RVR) rates associated with this triple therapy.