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ANA598 Demonstrates Positive 4-Week Results at 200 mg BID
Date:12/17/2009

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No patient experienced viral rebound (defined as >1 log10 increase from a prior measurement) through week 4. In accordance with the study protocol, four patients (three genotype 1a patients receiving placebo plus SOC and one genotype 1b patient receiving ANA598 plus SOC) discontinued either ANA598 or placebo at week 4 due to failing to reach at least 1 log10 viral load decline.

Preliminary Safety Assessment

Safety and tolerability from the interim analysis appeared similar between the active and placebo arms, with reported adverse events generally typical for interferon and ribavirin, although conclusions regarding longer-term safety and tolerability cannot be made until additional results over longer duration from this trial and future clinical trials in more patients are known. There were no discontinuations due to adverse events. Eight patients reported rash through the interim analysis date, seven mild and one moderate. For the six of twenty-nine patients (21%) receiving ANA598 plus SOC who reported rash, all cases were mild. For the two of fifteen patients (13%) receiving placebo plus SOC who reported rash, one case was mild and one case was moderate. There were no clinically meaningful changes in safety laboratory values and no changes in safety monitoring were recommended by the DMC in association with escalation to 400 mg bid.

Phase II Combination Study

In the ongoing Phase II study, treatment-naïve genotype 1 patients are to receive ANA598 or placebo in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) for 12 weeks at dose levels of 200 mg or 400 mg both given twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients are to continue receiving SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48.
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SOURCE Anadys Pharmaceuticals, Inc.
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