ViroPharma and Wyeth Initiate Dosing in Phase 2 Study of HCV-796 in Treatment Naive Patients and Non-Responders

ViroPharma Incorporated today announced that patient dosing has commenced in a Phase 2 study of HCV-796, a unique orally dosed hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV). The Phase 2 study is being conducted with Wyeth Pharmaceuticals, a division of Wyeth ViroPharma's partner in development of HCV-796.

The objectives of this trial are to assess the safety, tolerability, pharmacokinetic profile, and antiviral activity of HCV-796, when used in combination with pegylated interferon alfa-2b plus ribavirin compared to the current standard of care in treatment-naive subjects with HCV genotype 1 infection and in patients with HCV genotype 1 infection who were non-responders to prior HCV therapy. The companies will add an additional dose or doses of HCV-796 to the trial to further elucidate the dose response.

"Following the strength of the Phase 1 data, we have initiated a Phase 2 program to assess the efficacy of the compound as part of a triple therapy combination, and to continue to add to our safety database," commented Stephen Villano, M.D., ViroPharma's vice president of clinical research and development. "Hepatitis C is one of the most important unmet medical needs today. In the U.S., up to 70 percent of the estimated 3.2 million chronically infected persons will develop chronic liver disease, which is the single leading factor contributing to the need for a liver transplant in the U.S. each year. The current standard of care presents a problem for patients in terms of its cure rate and tolerability, and we believe that with continued clinical success HCV-796 could become part of combination therapies that we hope will produce a much higher cure rate for patients in the future."


More viral replication inhibitors (polymerases) here. Interferon is a naturally occuring cytokine protein that the body makes in response to viral infections; it is pegylated to make it more stable for sustained action once inside the body, usually injected into the abdomen. It is supposed to target other immune cells to kill virally infected cells. The side effects are hardly worth the benefits, thus the high interest in other mechanisms of action for HCV. Ribavirin is a standard treatment.

Wyeth (NYSE: WYE) is up at this hour 13 cents while ViroPharma (Nasdaq: VPHM) is unchanged in afternoon trading.