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Anadys Pharmaceuticals Reports First Quarter 2009 Financial Results and Highlights
Date:4/23/2009

n the recently completed Phase Ib clinical trial of ANA598 in HCV patients in a late-breaker poster entitled, "Antiviral Activity of ANA598, a Potent Non-Nucleoside Polymerase Inhibitor, In Chronic Hepatitis C Patients," at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL). In the Phase Ib study, ANA598 treatment resulted in rapid and sustained reductions in HCV RNA with median reductions at end of treatment (Day 4) exceeding 2 log10 (>99%) at all dose levels. At 200 mg bid, the median viral load reduction was 2.4 log10 (range of 0.4 to 3.4); at 400 mg bid, 2.3 log10 (range of 1.6 to 3.5); and at 800 mg bid, 2.9 log10 (range of 2.2 to 3.4). Genotype 1a patients demonstrated median reductions of 1.4 log10, 1.8 log10, and 2.5 log10 at 200, 400 and 800 mg bid, respectively. In 10 of the 12 genotype 1a patients who received ANA598, viral load was still declining at the end of the three days of treatment. Genotype 1b patients demonstrated median reductions of 2.6 log10, 2.5 log10 and 3.2 log10, at 200, 400 and 800 mg bid, respectively. No patient showed evidence of viral rebound while on ANA598. ANA598 was well-tolerated in this short term study and there were no serious adverse events.

  • 14-day Healthy Volunteer Study. Anadys recently completed dosing healthy volunteers in a 14-day study conducted to extend the safety and pharmacokinetic profile of ANA598. Thirty subjects participated in the study, with eight subjects receiving ANA598 and two subjects receiving placebo at each dose level (400 mg once-daily, 800 mg once-daily and 600 mg bid). Subjects received a single dose on day one followed by pharmacokinetic assessment over days two and three and received subsequent doses consecutively on days four through fourteen. Preliminary results from the study indicate that ANA598 was generally well-tolerated in all cohorts with no serious adverse events, al
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SOURCE Anadys Pharmaceuticals, Inc.
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