Dr. Worland added, "I want to acknowledge the tremendous effort and commitment of all our Anadys colleagues, especially those whose positions have been impacted by this restructuring. The current status of ANA598, which now demands our focused investment, has been achieved as a result of each of their contributions."
Proposed ANA598 Phase II Trial Design
Anadys is preparing for the first Phase II trial in hepatitis C patients of ANA598 in combination with interferon-alpha and ribavirin (current standard of care, or SOC) and intends to submit a protocol to the U.S. Federal Drug Administration (FDA) containing the proposed trial design in July 2009. If the FDA allows this trial to proceed, Anadys intends to initiate the trial during the third quarter of 2009.
The current protocol design calls for 12 weeks of dosing ANA598 in naive genotype 1 patients in combination with SOC, compared to a control arm that will receive a placebo and SOC. After 12 weeks, patients are expected to continue to receive SOC alone. The primary endpoints of the study are designed to be safety, tolerability and the percentage of patients with undetectable virus at four weeks (defined as Rapid Virologic Response, or RVR) and 12 weeks (defined as Early Virologic Response, or EVR). For patients who achieve an RVR and EVR response, the duration of treatment with SOC after week 12 will be at the clinical investigator's discretion. Anadys expects that some patients who achieve RVR would stop receiving all treatment at 24 weeks. All patients who complete 24 or 48 weeks of treatment will be assessed for virus negativity 12 and 24 weeks after treatment is ended.
The proposed dose levels in this study are 200 mg and 400 mg, each dosed twice daily (bid). In order to maximize early viral suppression, eac
|SOURCE Anadys Pharmaceuticals, Inc.|
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