Tuesday, biotechnology company InterMune, Inc. (ITMN) and antiviral drug developer Pharmasset, Inc. (VRUS) announced results from all patient cohorts of the INFORM-1 trial, an innovative Phase 1 study of two direct-acting antiviral, or DAA, compounds administered without interferon or ribavirin for the treatment of patients chronically infected with the hepatitis C virus.
The study, conducted by Roche as part of its collaborations with InterMune and Pharmasset, combined the oral NS3 protease inhibitor RG7227 and the oral nucleoside analog polymerase inhibitor RG7128.
The full dose combination of RG7128 1000mg and RG7227 900mg administered twice-daily without pegylated interferon or ribavirin, the current standard of care for HCV, for 13 days resulted in 88% of HCV-positive treatment-naive patients achieving HCV RNA below the lower limit of quantification, and 63% of patients having HCV RNA below the lower limit of detection.
The company stated that all patients receiving a twice-daily regimen experienced a continual decline in HCV RNA during the study period. Viral decline displayed a biphasic pattern with a rate of HCV RNA decline in the second phase that was similar to that observed when a single direct acting antiviral is added to pegylated interferon and ribavirin. No treatment-emergent resistance to RG7227 or RG7128 was observed in the study.
The all-oral, interferon-free combination showed promising safety and tolerability, the company said.
The companies also announced that a Mid-stage program of multiple studies will be initiated by Roche in the first quarter of 2010.
ITMN is currently being traded at $13.80 up $1.09 or 8.58% on a volume of 0.550 million shars on the Nasdaq.
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