ViroPharma Incorporated announced the initiation of a proof of concept clinical study with HCV-086, a hepatitis C antiviral compound that the company is co-developing with Wyeth.

The study will assess the antiviral activity, safety, and pharmacokinetic profile of the drug compared to placebo. In February of 2004, ViroPharma and Wyeth initiated the first Phase 1 trial with HCV-086, a single dose, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of the compound administered orally to healthy volunteers. Preliminary data from this single dose trial suggest that HCV-086 is well tolerated, with a favorable pharmacokinetic profile.

"We are excited to initiate this important study with this promising and unique molecule," said Dr. Colin Broom, ViroPharma's chief scientific officer. We now have agreement from the FDA that the data from the first Phase 1 trial in healthy volunteers allow us to progress to a repeat dose study, in which we will determine the activity of the molecule in HCV-positive patients. We expect to start dosing in this trial in early July, and have proof of concept data for the molecule by the end of the fourth quarter. If positive, these data should support the initiation of phase 2 clinical testing in 2005," he added.

This clinical trial is a randomized, double blind, multiple ascending dose, placebo controlled study at a leading clinical research facility in the United States involving 96 patients with chronic HCV infection.

ViroPharma and Wyeth are engaged in a collaboration to develop and commercialize antiviral compounds to treat hepatitis C. In addition to HCV-086, the companies are continuing to advance an additional, next-generation HCV antiviral compound through preclinical testing.

HCV-086 is an orally dosed molecule that has the potential to interfere with the replication of hepatitis C virus (HCV).