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Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
Date:9/24/2008

ed to display substantial antiviral activity based on preclinical results. Additionally, absorption was enhanced when ANA598 was taken with food, indicating that it should not be necessary to take ANA598 on an empty stomach in order to achieve desired plasma drug levels.

Additional detail from the Phase I study, including full PK results from the twice-daily 800 mg cohort, will be presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), to be held in San Francisco, California, October 31 - November 4, 2008. Abstracts can be viewed at the AASLD website at http://www.aasld.org.

ANA598 Program Update

Anadys is now finalizing preparations to begin a Phase Ib trial of ANA598 in HCV patients early in the fourth quarter. The study will be conducted at several sites in the United States. The regulatory review necessary to initiate the study has been completed. In the Phase Ib monotherapy study, naive genotype 1 patients will receive ANA598 over three days, at doses of 200 mg bid, 400 mg bid or 800 mg bid. Ten patients are planned to be enrolled in each of the three cohorts, eight on active treatment and two on placebo. Anadys expects to have viral load data from all three cohorts in the first quarter of 2009. Anadys may elect to explore other dose levels of ANA598 and/or once-daily dosing in this study, depending on data from the first three cohorts.

In September, Anadys initiated long-term chronic toxicology studies of ANA598. As communicated in April of this year, Anadys made the strategic decision to accelerate into 2008 certain non-clinical activities for the ANA598 program, including the initiation of these long-term toxicology studies and the manufacture of additional drug substance. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these non-clinical activities into 2008 will enable a more rapid
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SOURCE Anadys Pharmaceuticals, Inc.
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