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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

ted at all three doses in this study is very encouraging for the prospects of ANA598 when used in combination with other HCV agents. With the successful conclusion of this study in patients and the 14-day study in healthy volunteers, the positive 13-week animal toxicology results and ongoing manufacturing activities, the ANA598 program continues on track to be ready for Phase II in mid-2009."

The Phase Ib study was a randomized, double-blind, placebo-controlled, multiple ascending dose trial conducted to evaluate the safety, tolerability and antiviral activity of orally administered ANA598 in treatment-naive patients with chronic HCV genotype 1 infection. Patients were treated with ANA598 capsules (or matching placebo) at doses of 200 mg, 400 mg or 800 mg bid for three days. 35 patients participated in the study, with 11 receiving 200 mg bid, eight receiving 400 mg bid, eight receiving 800 mg bid and eight receiving placebo (with none of the patients receiving placebo showing an end of treatment response greater than 0.2 log10 reduction in viral load). Viral load at Day 4 (12 hours after the last dose) was compared to baseline HCV RNA levels.

"We're very pleased with the antiviral activity and safety of ANA598 in this study," commented James Freddo, M.D., Senior Vice President, Drug Development and Chief Medical Officer. "We believe the data continue to position ANA598 as a leading non-nucleoside polymerase inhibitor in development for the treatment of HCV, and we look forward to investigating ANA598 in longer-term studies in combination with current standard of care."

ANA598 Program Update

Anadys continues to make progress on all aspects of the ANA598 program, including toxicology, manufacturing and a recently completed 14-day clinical study in healthy volunteers. The Company reiterates its expectation for the program to be ready mid-year for the first Phase II study of ANA598 in combination wi
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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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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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