ViroPharma says HCV-795 shows promising hepatitis C antiviral activity

By E. Janene Geiss

Philadelphia, May 22 - ViroPharma Inc. said Monday that data from a phase 1b trial of HCV-796, an orally dosed non-nucleoside viral polymerase inhibitor with the potential to interfere with the replication of hepatitis C virus, show dose-related antiviral activity across multiple genotypes with peak response achieved at a 500 to 1,000 mg, twice-daily dose.

HCV-796 was administered as a monotherapy for 14 days, according to a company news release.

The drug candidate was well-tolerated in the study with no dose-limiting toxicities across the range of study doses, officials said.

Patients receiving HCV-796 rapidly achieved substantial reductions in alanine aminotransferase levels during the treatment period, officials added. Elevated ALT levels are common in hepatitis C patients and are considered to be a marker of liver injury due to hepatitis C infection.

The study results were presented at the Digestive Disease Week conference in Los Angeles. The drug is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth.

HCV-796 is in phase 1b testing in combination with PEG-interferon, officials said.

"These data allow us to proceed with optimism through the ongoing phase 1b study in combination with PEG-interferon," Steve Villano, ViroPharma's vice president of clinical research and development, said in the release.

This trial was a randomized, double-blind, placebo-controlled study of HCV-796 administered orally for 14 days to patients with chronic hepatitis C infection, who were naïve to treatment.

Peak antiviral response was achieved at doses of 500 twice-daily and higher. The 500 mg, 1,000 mg and 1,500 mg dose groups achieved peak mean hepatitis C viral load reductions of 96% to 97% on the fourth day of a 14-day dosing period.

ViroPharma is an Exton, Pa., biopharmaceutical company that develops products for physician specialists and in-hospital settings.

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