Sep. 9, 2009 (PR Newswire) --

SAN DIEGO, Sept. 9 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that dosing has begun in a Phase II trial of ANA598 in patients chronically infected with hepatitis C virus (HCV). The study will evaluate ANA598 over 12 weeks, taken in combination with pegylated interferon-alpha and ribavirin, in treatment naive HCV patients. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor.

"ANA598 has demonstrated potent antiviral activity and good tolerability as a single agent, as well as preclinical properties indicative of likely synergy when used clinically in combination regimens," said James Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. "We look forward to building upon these results to demonstrate the benefit of ANA598 when used in combination with interferon and ribavirin."

About the Phase II Study

In the Phase II study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys((R)) (peginterferon alfa-2a) and Copegus((R)) (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48. The primary endpoint of the study is the proportion of patients with undetectable virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained Virological Response, or SVR).

Ninety patients are planned to be enrolled in this study -- thirty patients receiving ANA598 and fifteen receiving placebo at each dose level. The study will be managed by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison, M.D. and will be conducted at a number of clinical sites in the United States.

Anadys expects to receive 28-day safety and response (RVR) data from the 200 mg dose level by year-end and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.

About ANA598

ANA598 is a non-nucleoside inhibitor of the HCV RNA polymerase. Anadys has completed three Phase I clinical studies of ANA598 that have demonstrated potent antiviral activity and good tolerability.