US biopharmaceutical company ViroPharma says that data from a study of HCV-796, designed to inhibit hepatitis C virus replication, demonstrates the compound's dose-related antiviral activity across multiple viral genotypes. The agent, which is an orally-dosed non-nucleoside viral polymerase inhibitor, is being co-developed by ViroPharma and Wyeth Pharmaceuticals.
The findings, which were presented at the annual Digestive Disease Week conference in Los Angeles, California, USA, are derived from a Phase Ib trial, during which the compound's antiviral activity was assessed in 796 patients chronically infected with the virus. Subjects were randomized to receive the product twice-daily across a range of doses (50mg, 100mg, 250mg, 1,000mg and 1,500mg) or placebo for a period of 14 days. The data showed that patients receiving two 500mg tablets per day and over, achieved a 96%-97% reduction in viral load. Additionally, the firm says that the results demonstrate that the agent was well tolerated, with no serious treatment-emergent adverse effects during the study. Mild-to-moderate headache was the most frequently reported adverse event.
Steve Villano, ViroPharma's vice president of clinical R&D, said that the compound is effective against HCV for a number of disease measures, across several viral genotypes and displayed no dose-limiting toxicities. He added that the firm would proceed with its plan to study the compound in combination with PEG-interferon in its ongoing Phase Ib program.
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