ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis ...(nd 39 weeks duration in monkeys. Based ...),Health

Date:4/23/2009

nd 39 weeks duration in monkeys. Based on a now completed analysis of data at the 13-week interim in both species, the No Observed Adverse Effect Level (NOAEL) in monkeys and male rats remains 1000 mg/kg at 13 weeks, the highest dose being tested in the chronic studies. In female rats the NOAEL at the 13-week interim was 300 mg/kg, with the only adverse finding in female rats, observed only in the 1000 mg/kg dose group, being a marginal decrease in the rate of weight gain. Anadys previously reported NOAELs in both species after 28 days of 1000 mg/kg, the highest dose tested in that study. The dosing portion of the 26-week study in rats is now complete, while the dosing portion of the 39-week study in monkeys is scheduled to conclude in June. Anadys expects that the results from these chronic toxicology studies, if continuing to be favorable, will enable dosing of ANA598 for up to 48 weeks in the Phase II study of ANA598 in combination with pegylated interferon and ribavirin.

ANA598 Preclinical Data at EASL Meeting

In addition to the results of the Phase Ib HCV patient study, Anadys is presenting additional data on the preclinical profile of ANA598 at the EASL Meeting at 4 p.m. CEST (7 a.m. PDT) on Friday, April 24. In an oral presentation, Anadys will present in vitro data showing that combinations of ANA598 with interferon-alpha, the protease inhibitor telaprevir and the nucleoside polymerase inhibitor PSI-6130 are synergistic. These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors, and non-nucleosides that, through virtue of binding at a different site than ANA598, display a resistance profile distinct from that of ANA598. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir and PSI-6130.

About ANA598

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SOURCE Anadys Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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