In addition to the data from the Phase II combination study, Anadys will also present data on the preclinical profile of ANA598 at the EASL meeting on Friday, April 16, 2010.  In a poster titled "Enhanced In Vitro Antiviral Activity of ANA598 in Combination with Other Anti-HCV Agents Support Combination Treatment," Anadys will present preclinical data showing enhanced antiviral activity and suppression of resistance when ANA598 is combined in vitro with other anti-HCV agents that act through diverse mechanisms, including protease inhibition, polymerase inhibition (both nucleoside and non-nucleoside inhibitors) and inhibition of host functions.  As of April 16, 2010, the poster will be accessible on the Company's website at www.anadyspharma.

Phase II Combination Study

In the ongoing Phase II study, a total of approximately 90 treatment-naive genotype 1 patients are to receive ANA598 or placebo in combination with Pegasys?® (peginterferon alfa-2a) and Copegus?® (ribavirin, USP) for 12 weeks at dose levels of 200 mg bid or 400 mg bid, each with a loading dose of 800 mg bid on day one.  After week 12, patients are to continue receiving 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 who achieve undetectable levels of 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 levels of virus at week 4 (defined as Rapid Virological Response, or RVR).  Patients will be followed for 24 weeks after stopping therapy to determine the rate of Sustained Virological Response, or SVR.  Approximately 90 patients have been enrolled in this study “ with approximately 30 patients receiving ANA598 plus SOC at each dose level and 30 patients receiving placebo plus SOC.  The study is being managed by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison, M.D. and is being conducted at a number of clinical sites in the United States.  

SOURCE Anadys Pharmaceuticals, Inc.