Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HC...( Safety and Pharmacokinetic Results in...),Health

Safety and Pharmacokinetic Results in Healthy Volunteers to be Presented at

AASLD

SAN DIEGO, Sept. 24 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today preliminary results of a Phase I clinical trial of ANA598 in healthy volunteers and finalization of the protocol for a Phase Ib trial of ANA598 in patients chronically infected with hepatitis C virus (HCV). In the healthy volunteer study, ANA598 was well tolerated at all doses analyzed to date and no serious adverse events were reported. All doses achieved plasma drug concentrations predicted to display substantial antiviral activity based on preclinical results. The upcoming Phase Ib study of ANA598 in HCV patients will explore three dose levels -- 200 mg, 400 mg, and 800 mg, each taken twice daily (bid). ANA598 is the company's investigational hepatitis C non-nucleoside polymerase inhibitor.

Phase I Study Results

In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single doses starting at 400 mg. At the 2000 mg dose level, it was administered when fasted and also following a meal. In addition, a separate cohort received two 800 mg doses twelve hours apart. ANA598 was well tolerated at all doses analyzed to date and no serious adverse events were reported, 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. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of more than 24 hours, consistent with the potential for once-daily or twice-daily oral dosing. All doses achieved plasma drug concentrations predict
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