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ANA598 Demonstrates SVR12 in 100% of First Group of HCV Patients Randomized to Stop All Treatment at Week 24
Date:7/29/2010

In the ongoing Phase II study, approximately 90 treatment-naive genotype 1 HCV patients have received 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 achieved undetectable levels of virus at weeks 4 and 12 were 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) and is being conducted at a number of clinical sites in the United States.  

About ANA598

ANA598, a direct-acting antiviral or DAA, is a non-nucleoside inhibitor of the HCV RNA polymerase and is wholly owned by Anadys.  In an ongoing Phase II study in which HCV patients received ANA598 at 200 mg bid or 400 mg bid in combination with interferon and ribavirin for twelve weeks, both dose levels showed comparable cEVR rates of 73-75% and a favorable safety profile.  In a previous Phase I study,
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SOURCE Anadys Pharmaceuticals, Inc.
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Related medicine technology :

1. 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
2. Anadys Pharmaceuticals Announces Positive Results for ANA598 in Animal Model of Chronic Hepatitis C Virus Infection
3. Anadys Pharmaceuticals Presents Data on ANA598, a Non-Nucleoside Inhibitor of the HCV Polymerase, at the 21st International Conference on Antiviral Research
4. Anadys Pharmaceuticals Initiates Phase I Clinical Trial of ANA598
5. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
6. Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers
7. ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients
8. ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients
9. Anadys Pharmaceuticals Commences Dosing in Phase II Study of ANA598
10. ANA598 Demonstrates Positive 4-Week Results at 200 mg BID
11. Cytokine Demonstrates Oral Efficacy of Small-Molecule MIF Inhibitors
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