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Anadys Pharmaceuticals Commences Dosing ANA598 in Hepatitis C Patients in Phase Ib Study
Date:10/28/2008

SAN DIEGO, Oct. 28 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that it has initiated dosing ANA598 in patients chronically infected with hepatitis C virus (HCV) in a Phase Ib study. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor. The Phase Ib clinical trial is a double-blind, placebo-controlled study that will evaluate the tolerability, pharmacokinetics and viral kinetics of multiple, ascending doses of ANA598 over a period of three days. Anadys expects to enroll approximately 30 patients in the study of ANA598 at doses of 200 mg bid (twice-a-day), 400 mg bid and 800 mg bid.

"ANA598 demonstrated favorable tolerability and pharmacokinetics as a single dose in healthy volunteers in our recently concluded Phase I study," said James Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. "We look forward to building upon these results and testing the compound in HCV patients, first in this monotherapy study and subsequently in combination studies. We expect the maximal benefit of direct antivirals to be realized when used in combination regimens incorporating multiple anti-HCV agents."

ANA598 Phase Ib Study

In the Phase Ib monotherapy study, ANA598 will be administered to naive genotype 1a and 1b patients over three days, at doses of 200 mg bid, 400 mg bid or 800 mg bid. Ten patients are planned to be enrolled in each of the three cohorts - eight on active treatment and two on placebo. Anadys expects to have viral load data from all three cohorts in the first quarter of 2009. Anadys may elect to explore other dose levels of ANA598 and/or once-daily dosing based on data from the first three cohorts.

About ANA598

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SOURCE Anadys Pharmaceuticals, Inc.
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