Anadys Drug Meets Key Study Goals - Analyst Blog

Anadys Pharmaceuticals Inc. (ANDS) announced that its lead candidate, ANA598, which is being developed for treating patients with hepatitis C virus (HCV) infections has met its key goals in a mid-stage study.
 
The study saw HCV patients being treated with ANA598 in combination with pegylated interferon and ribavirin - the current standard of care (SOC) - at a 200 mg bid dosage level and analyzed at four weeks. The drug was generally well tolerated. No discontinuations because of serious adverse events were reported even though eight patients, seven mild and one moderate, developed rash in the interim analysis.
 
The interim data from the four-week analysis revealed that 56% patients who received the HCV drug in combination with the SOC showed undetectable traces of the virus, Rapid Virological Response (RVR), at four weeks, compared to 20% of patients who received placebo combined with the SOC.
 
The Phase II trial is designed to evaluate the Anadys HCV drug in combination with pegylated interferon and ribavirin at 200 mg and 400 mg dosage levels. The study will see patients receiving the HCV candidate of Anadys for 12 weeks, which will be followed by the SOC treatment for 12 or 36 more weeks. An independent Data Monitoring Committee, responsible for reviewing the safety data has recommended escalating to the 400 mg dosage level. Enrollment is underway for testing the drug at the higher dosage level for which Anadys expects to commence dosing in January 2010.
 
Even if ANA598 can navigate through the clinical and regulatory hurdles smoothly, it still faces tough competition in the HCV market. This market is dominated by Roche (RHHBY), which commands a majority of the U.S. and global pegylated interferon market through the sale of Pegasys/Copegus and Merck (MRK) which sells Peg-Intron / Rebetrol.
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