Swiss drug giant Roche Holding AG (RHHBY.PK, RHHVF.PK) and InterMune Inc. (ITMN) Wednesday announced the start of a mid-stage trial to evaluate hepatitis C virus protease inhibitor, RG7227/ ITMN-191, in combination with Pegasys and Copegus.
The study is to be conducted at 45 sites globally, and will enroll about 300 patients. The study will further define the safety and efficacy profile of RG7227/ITMN-191 for a treatment duration of up to 24 weeks.
RG7227/ITMN-191 is being developed in partnership by Roche and InterMune. With the initiation of the phase 2b trial, InterMune will receive a $20 million event payment from Roche under a collaboration agreement.
The objective of the Phase 2b randomized, double-blind, placebo-controlled study is to further characterize the safety, tolerability, and antiviral effects of RG7227/ITMN-191 in triple combination, compared with standard of care, PEGASYS plus COPEGUS.
Roche and InterMune also plan to initiate a phase 1 trial combining RG7227/ITMN-191 with low dose ritonavir to examine the virologic effect of ritonavir-boosted RG7227/ITMN-191 in once-daily and twice-daily regimens in combination with standard dosing of PEGASYS and COPEGUS in patients chronically infected with HCV genotype 1.
RG7227/ITMN-191 is also being investigated in combination with the NS5B polymerase inhibitor RG7128 in the INFORM-1 study.
ITMN closed Wednesday's regular trading session at $14.49, up 58 cents or 4.17%. However, in the after-hours, the share lost 58 cents or 4.00%.
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