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ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients
Date:4/23/2009

s retains worldwide rights to ANA598, which was fully discovered at the Company. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In December 2008, Anadys announced that the FDA granted fast track designation to ANA598 for the treatment of chronic HCV.

In October 2008, Anadys initiated patient dosing in the Phase Ib study of ANA598 in HCV patients and in February 2009 Anadys initiated dosing in a 14 day study in healthy volunteers.

In an earlier Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study. All reported adverse events were classified as mild or moderate, with no apparent dose relationship. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 consistent with the potential for once-daily or twice-daily oral dosing.

In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September 2008, Anadys initiated long-term, chronic toxicology studies of ANA598.

If ANA598 is successful in early stage development, the Company anticipates completion of the clinical, toxicology and manufacturing activities required to initiate Phase II studies of ANA598 in combination with current standard of care in mid-2009.

Clinical Need and Market Opportunity in HCV Infection

Chronic HCV infection is a serious public health concern affecting ap
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SOURCE Anadys Pharmaceuticals, Inc.
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1. ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients
2. Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers
3. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
4. Anadys Pharmaceuticals Initiates Phase I Clinical Trial of ANA598
5. Anadys Pharmaceuticals Presents Data on ANA598, a Non-Nucleoside Inhibitor of the HCV Polymerase, at the 21st International Conference on Antiviral Research
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