November 4, 2008
Anadys Reports Encouraging Results From Phase I Hepatitis Study
Anadys Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced 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 hepatitis C virus.
In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400mg, 800mg, 1400mg, 2000mg and 3000mg. In addition, a separate cohort received two 800mg 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.
According to the company, 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 800mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83mcg/ml, which substantially exceeds the level predicted to display antiviral potency.
Anadys also reported the data from in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). 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 bind at the thumb site.