Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy ...( Phase I Clinical Data and Additional ...),Health

Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside

HCV Polymerase Inhibitor Being Presented at AASLD

SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor.

ANA598 Phase I Study Results

In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg
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