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Anadys Announces Issuance of U.S. Patent Covering Setrobuvir (ANA598)
Date:6/1/2011

, setrobuvir (ANA598) is being tested in combination with Pegasys® and Copegus® in both treatment-naive patients and patients who failed a prior course of therapy with interferon and ribavirin.  Dosing is underway and approximately 275 patients are expected to be enrolled in the study.  The primary endpoint of the study is Sustained Virological Response 24 weeks after patients complete treatment, known as SVR24.  The Company expects to receive antiviral response data through 12 weeks for all patients, including the 8 week timepoint used for response-guided therapy in treatment-naive patients, in the third quarter of 2011.  Antiviral response data through 24 weeks are expected in the fourth quarter of 2011.  

Prior Clinical and Preclinical Profile of Setrobuvir (ANA598)

In an earlier Phase IIa study, setrobuvir (ANA598) demonstrated potent antiviral activity, as well as good safety and tolerability in combination with interferon and ribavirin through 12 weeks of dosing in treatment-naive genotype 1 HCV patients.  In a completed Phase I study, setrobuvir demonstrated potent antiviral activity in a three day monotherapy study in treatment-naive genotype 1 patients.  To date, setrobuvir has demonstrated an excellent resistance profile in HCV patients.

Setrobuvir (ANA598) has also been characterized in a variety of preclinical studies.  In completed long-term chronic toxicology tests in both rats and monkeys, the No Observed Adverse Effect Level, or NOAEL, was 1000 mg/kg, the highest dose tested.  Data from preclinical models of antiviral activity have laid the foundation for clinical investigation of setrobuvir (ANA598) in DAA combinations.  In particular, synergistic antiviral activity in vitro was observed when setrobuvir (ANA598) was combined with a number of approved or investigational HCV agents, and in vitro combinations of setrobuvir (ANA598) with other DAAs from
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SOURCE Anadys Pharmaceuticals, Inc.
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