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Anadys Pharmaceuticals Reports Third Quarter 2008 Financial Results and Highlights
Date:10/23/2008

Ib Clinical Trial of ANA598. Anadys has completed preparations required to initiate a Phase Ib clinical trial of ANA598, an investigational oral non-nucleoside polymerase inhibitor for the treatment of hepatitis C virus (HCV) infection, and expects to initiate patient dosing shortly. ANA598 will be administered to naive genotype 1a and 1b patients at 200 mg bid (twice-a-day), 400 mg bid or 800 mg bid over a period of three days. Anadys expects to have viral load data from this study in the first quarter of 2009. Based on the data from the first three cohorts, Anadys may elect to explore once daily dosing and/or other dose levels of ANA598.

-- Conclusion of Healthy Volunteer Study in Phase I Clinical Trial of ANA598. In September, Anadys announced preliminary results of the Phase I clinical trial of ANA598 in healthy volunteers and finalization of the protocol for a Phase Ib trial of ANA598 in HCV infected patients. ANA598 was well tolerated at all doses tested, and all doses achieved plasma drug concentrations predicted to display substantial antiviral activity based on preclinical data. Safety and PK data from all dose levels in the Phase I clinical trial of ANA598 will be presented in a late-breaker poster session on November 3 at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), to be held in San Francisco, California. Further preclinical data on ANA598 will be presented at AASLD in two additional poster presentations on November 4.

-- Initiation of Long-Term Chronic Toxicology Studies of ANA598. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009.

-- Phase I Clinical Trial of ANA773 in HCV. In July, Anadys announced that it was resuming
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SOURCE Anadys Pharmaceuticals, Inc.
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