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Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients
Date:7/30/2009

ent safety and response data from both cohorts during the first two quarters of 2010.

"ANA598 has demonstrated potent antiviral activity and good tolerability as a single agent in Phase I, as well as preclinical properties indicative of likely synergy when used clinically in combination regimens," said Steve Worland, Ph.D., President and CEO of Anadys. "We are now in a position to demonstrate the value of ANA598 when used in combination in a Phase II trial to treat hepatitis C patients. This trial incorporates several attractive features designed to further enhance the competitive position of ANA598, including twelve weeks of triple combination treatment and a randomized exploration of shortening the overall duration of HCV therapy in conjunction with ANA598 treatment."

About ANA598

ANA598 is a non-nucleoside inhibitor of the HCV RNA polymerase. Anadys has completed three Phase I clinical studies of ANA598 that have demonstrated potent antiviral activity and good tolerability. In a monotherapy study in naive genotype 1 patients, treatment with ANA598 for three days led to median declines in viral load ranging from 2.4 to 2.9 log10 in three separate dose groups. No patient at any dose level showed evidence of viral rebound while on ANA598, and there were no serious adverse events.

Anadys has completed dosing in two long-term chronic toxicology studies of ANA598 (26 weeks duration in rats and 39 weeks duration in monkeys). At the 13-week interim, the toxicology profile of ANA598 in both species was very favorable. A preliminary assessment of the results from the 26-week study in rats indicates a similar profile to that seen in rats at 13 weeks, in which the only adverse finding was a marginal decrease in the rate of weight gain in females at 1000 mg/kg, the highest dose tested. Complete results from both studies, including 39-week data from the monkey study, are expected at
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SOURCE Anadys Pharmaceuticals, Inc.
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