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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

th pegylated interferon and ribavirin. The actual timing for the initiation of Phase II studies may depend on a number of factors, including FDA review timelines, the timing of any potential transaction around ANA598 or ANA773, available cash resources and funding activities, and the engagement of clinical sites.

14 Day Healthy Volunteer Study

Anadys recently completed dosing healthy volunteers in a 14-day study conducted to extend the safety and pharmacokinetic profile of ANA598. Thirty subjects participated in the study, with eight subjects receiving ANA598 and two subjects receiving placebo at each dose level (400 mg once-daily, 800 mg once-daily and 600 mg bid). Subjects received ANA598 or placebo on day one followed by pharmacokinetic assessment over days two and three and received subsequent doses consecutively on days four through fourteen. Preliminary results from the study indicate that ANA598 was generally well-tolerated in all cohorts with no serious adverse events, although three subjects receiving ANA598 (two in the 800 mg once-daily cohort and one in the 600 mg bid cohort) developed grade 2 rash and discontinued treatment after either six or seven days of consecutive dosing. There were no other instances of rash in this or any other study of ANA598. Data receipt and analysis from this study is continuing, and the Company expects to present the results at a clinical conference later this year. The Company believes the results of this study, combined with the results of the Phase Ib study in HCV patients, contribute to the attractive profile of ANA598 as an antiviral likely to be active in long-term studies in combination with pegylated interferon and ribavirin, and help position the program to be ready for Phase II in mid-2009.

Long-term Toxicology Studies

In September 2008, Anadys initiated long-term, chronic toxicology studies of ANA598, of 26 weeks duration in rats a
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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
6. Anadys Pharmaceuticals Announces Positive Results for ANA598 in Animal Model of Chronic Hepatitis C Virus Infection
7. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
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