InterMune, Inc. (Nasdaq: ITMN) today announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified.
The Phase 2b study has four dosage cohorts: SOC; 300mg q8h plus SOC; 600mg q12h plus SOC and 900mg q12h plus SOC. To date, approximately 175 patients have been enrolled in the study.
Three patients in the blinded 900 mg q12h dosage cohort experienced a Grade 4 elevation in ALT levels, one of whom experienced an elevation of total bilirubin while also receiving concomitant allopurinol. After their review of the un-blinded data from all cohorts, the study's independent Data Monitoring Committee (DMC) recommended that the 900mg q12h cohort be discontinued and that all other cohorts of the study continue. The companies accepted the DMC's recommendations. The on-going Phase 2b study is blinded and consequently, additional details will not be provided.
As previously disclosed, the company anticipates the results of blinded rapid virologic response (RVR) data from the 12-week treatment duration cohorts in the first quarter of 2010. The company also reported that the on-going ritonavir boosting study of low-dose ITMN-191 continues to enroll patients and that guidance for INFORM-2 and for a longer duration Phase 2 study of the combination of direct acting antivirals to evaluate sustained virologic response (SVR) is not expected to change at this time.