Biotechnology company InterMune Inc. (ITMN), Monday reported preliminary results from two cohorts of the Phase 1b multiple-ascending-dose study for protease inhibitor RG7227 for the treatment of patients chronically infected with the hepatitis C virus or HCV. The company also reported guidance for the 2010 milestones and key events for RG7227.
The company said that the majority of patients for the 15 days study administered twice daily with 100 mg RG7227, formerly referred to as ITMN-191, along with low-dose ritonavir in combination with standard of care or SOC, or 200 mg RG7227 once-daily were found to be HCV RNA negative at the end of therapy. The ritonavir-boosted regimen provided more favorable pharmacokinetic profile compared to 900 mg RG7227 administered twice-daily with, SOC and without ritonavir. No drug related serious adverse events have been reported to date. Brisbane, California-based InterMune said it expects to begin Phase 2b triple combination study by third quarter of 2010. Positive Phase 1b results, the company decided to terminate its previously planned 24-week un-boosted part of the on-going Phase 2b study.
The enrollment for the Phase 2b trial was started in August 2009 for RG7227 in combination with Pegasys or pegylated interferon alfa-2a and copegus or ribavirin to study both 600 mg and 900 mg q12h given twice daily and three-times-daily regimens 300 mg q8h for 12-week and 24-week treatment durations. InterMune on November 17, 2009 said that three patients in the blinded 900 mg q12h dosage cohort experienced an ACTG Grade 4 elevation in ALT levels, one of whom experienced an elevation of total bilirubin while also receiving concomitant allopurinol.
The study's independent Data Monitoring Committee or DMC after reviewing the un-blinded data recommended the discontinuation of 900 mg q12h cohort.The company said that the enrollment of all remaining cohorts was completed in November of 2009.
In addition, the companies plan to amend the on-going Phase 1b MAD 15-day ritonavir boosting study to evaluate 12 weeks of RG7227 ritonavir-boosted therapy plus SOC. Earlier, the company reported positive results of a Phase 1 study of ritonavir-boosted RG7227 in healthy volunteers.
Looking ahead, InterMune expects results for the un-blinded rapid virologic response and early virologic response data from the on-going Phase 2b study of RG7227 plus SOC in the late first quarter or early second quarter of 2010.
The company estimates that the initiation of INFORM-2 program based ritonavir-boosted RG7227 plus RG7128 will be in the first quarter and initiation of longer duration DAA study to evaluate SVR ritonavir boosted in the second quarter. The initiation for the new study of Phase 2b study of ritonavir-boosted RG7227 plus SOC will be in the third quarter of 2010.
ITMN is currently trading at $14.85, down $0.07 or 0.50% on a volume of 518,481 million shares on the Nasdaq.
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