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The study will evaluate ANA598 over 12 weeks, taken in combination with pegylated interferon-alpha and ribavirin, in treatment naive hepatitis C virus (HCV) patients. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor.
In the Phase II study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys and Copegus for 12 weeks at dose levels of 200mg or 400mg twice daily (bid), each with a loading dose of 800mg bid on day one. After week 12, patients will continue to receive standard of care. Patients who achieve undetectable levels of virus at weeks four 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 with undetectable virus at week 12. Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week four, weeks 24 and 48, and 24 weeks after stopping all treatment.
Approximately 90 patients are planned to be enrolled in this study - 30 patients receiving ANA598 and 15 receiving placebo at each dose level. The study will be managed by the Duke Clinical Research Institute under the leadership of John McHutchison and will be conducted at a number of clinical sites in the US.
Anadys expects to receive 28-day safety and response data from the 200mg dose level by year-end and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.
James Freddo, chief medical officer of Anadys, said: "ANA598 has demonstrated potent antiviral activity and good tolerability as a single agent, as well as preclinical properties indicative of likely synergy when used clinically in combination regimens. We look forward to building upon these results to demonstrate the benefit of ANA598 when used in combination with interferon and ribavirin."
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