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news.Anadys Pharmaceuticals has reported that ANA598, the company's investigational non-nucleoside polymerase inhibitor, demonstrated potent antiviral activity at all dose levels and was well tolerated in a Phase Ib study in which patients chronically infected with the hepatitis C virus were treated for three days.
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In the study, ANA598 treatment resulted in rapid and sustained reductions in hepatitis C virus (HCV) RNA with median reductions at end of treatment (day four) exceeding 2 log10 (>99%) at all dose levels, the company said. At 200mg bid (twice-daily), the median viral load reduction was 2.4 log10 (range of 0.4 to 3.4); at 400mg bid, 2.3 log10 (range of 1.6 to 3.5); and at 800mg 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 800mg 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 800mg 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, said Anadys.
The Phase Ib study was a randomized, double-blind, placebo-controlled, multiple ascending dose trial conducted to evaluate the safety, tolerability and antiviral activity of orally administered ANA598 in treatment-naive patients with chronic HCV genotype 1 infection.
Patients were treated with ANA598 capsules at doses of 200mg, 400mg or 800mg bid for three days. A total of 35 patients participated in the study, with 11 receiving 200mg bid, eight receiving 400mg bid, eight receiving 800mg bid and eight receiving placebo. Viral load at day four was compared to baseline HCV RNA levels.
Steve Worland, president and CEO of Anadys, said: “The potent antiviral activity demonstrated at all three doses in this study is very encouraging for the prospects of ANA598 when used in combination with other HCV agents. With the successful conclusion of this study in patients and the 14-day study in healthy volunteers, the positive 13-week animal toxicology results and ongoing manufacturing activities, the ANA598 program continues on track to be ready for Phase II in mid-2009.”