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Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers
Date:11/1/2008

al effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose.

About ANA598

Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers.

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 the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009.

Clinical Need and Market Opportunity in HCV Infection

Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the live
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SOURCE Anadys Pharmaceuticals, Inc.
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1. Anadys Pharmaceuticals to Present at the JMP Securities Healthcare Focus Conference
2. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
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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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