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ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection
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Monday, December 01, 2008 6:38 PM
SAN DIEGO, Dec. 1 Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to ANA598 for the treatment of chronic hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C non-nucleoside polymerase inhibitor. Anadys is currently enrolling patients in a Phase Ib study evaluating ANA598 for the treatment of patients chronically infected with HCV.
Under the FDA Modernization Act of 1997, fast track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions. Compounds selected must demonstrate the potential to address an unmet medical need for such a condition. Mechanisms intended to facilitate development include opportunities for frequent dialogue with FDA reviewers and for timely review of submitted protocols. However, the designation does not guarantee approval or expedited approval of any application for the product. The granting of fast track status for the ANA598 development program is consistent with the need for HCV treatments with novel mechanisms of action, oral administration, non-overlapping resistance profiles and improved safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients.
'The FDA's fast track designation for ANA598 acknowledges the need for new HCV therapies to improve treatment outcomes,' commented James Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. 'We anticipate continuing to work closely with the FDA on the development and regulatory review of ANA598, one of the few non-nucleoside polymerase inhibitors in clinical development for the treatment of HCV. We continue to believe this class of antivirals holds great promise as a component of future HCV treatment regimens.'
About ANA598
Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. In the Phase Ib study, naive genotype 1a and 1b patients are to receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo.
In a 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.
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