- Reported Positive Phase II Combination Data. In December 2009, Anadys announced preliminary results from a planned interim analysis of data at four weeks for the first dose cohort, 200 mg given twice daily (bid), in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients. At each week, a greater proportion of patients receiving ANA598 plus SOC achieved undetectable levels of virus compared to patients receiving placebo plus SOC, with 56% of patients in the ANA598 group having undetectable levels of virus at week four. ANA598 was well tolerated through four weeks, with no serious adverse events reported.
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In the ongoing Phase II study, treatment-naive genotype 1 patients are to receive ANA598 or placebo in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) for 12 weeks at dose levels of 200 mg or 400 mg both given twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients are to continue receiving SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48. The primary endpoint of the study is the proportion of patients who achieve undetectable levels of virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable levels of virus at week 4 (defined as Rapid Virological Response, or RVR). Patients will be followed for 24 weeks after stopping therapy to determine the rate of Sustained Virological Response, or SVR. Approximately 90 patients were to be and have been enrolled in this study – with approximately 30 patients receiving ANA598 and 15 receiving placebo at each dose level. The study is being managed by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison, M.D. and is being conducted at a number of clinical sites in the United States.
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- Reported Potent Antiviral Activity/Good Tolerability at EASL. In April 2009, Anadys reported data at the 44th Annual Meeting of the European Association of the Study of Liver Disease demonstrating potent antiviral activity and good tolerability of ANA598 as a single agent at all dose levels in a Phase Ib study, in which ANA598 was dosed for three days in HCV patients. No patient at any dose level showed evidence of viral rebound while on ANA598 and there were no serious adverse events reported.
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- Reported 14-day Healthy Volunteer Study Results. In April 2009, Anadys reported that ANA598 was generally well-tolerated in all cohorts with no serious adverse events in a 14-day monotherapy study of ANA598 in healthy volunteers. Pharmacokinetic results from this trial confirmed the plasma half-life of ANA598 of approximately 24 hours, and demonstrated that steady-state levels of ANA598 in plasma are reached after six to seven days of dosing.
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- Favorable Toxicology Profile Established. In October 2009, Anadys completed its long-term, chronic toxicology studies of ANA598 and reported that the No Observed Adverse Effect Level, or NOAEL, is 1000 mg/kg (the highest dose tested) in both species tested. The completed studies confirm the favorable toxicology profile of ANA598 and support dosing durations of as long as one year if desirable in future clinical studies.
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