Anadys to begin phase 1b trial for ANA975 in hepatitis C patients

By E. Janene Geiss

Philadelphia, Dec. 22 - Anadys Pharmaceuticals, Inc. said Thursday that it plans to start a phase 1b, placebo-controlled, multiple-dose clinical trial of ANA975 in chronic hepatitis C patients in January.

The trial, which will be conducted at multiple sites in the United States and Europe, is designed to evaluate the safety, tolerability and viral load reduction of ANA975 for 28 days in chronically infected hepatitis C patients, according to a company news release.

ANA975, which Anadys is developing in collaboration with Novartis, is the oral prodrug of isatoribine, a proprietary toll-like receptor-7 (TLR7) agonist, officials said.

Patients will be assigned randomly to one of two main categories. In one category patients will receive either a predetermined dose of ANA975 once a day for 28 days or a placebo.

In a second category patients will receive a predetermined dose of ANA975 twice a day for 28 days or a placebo.

The company said it expects to report clinical data from this study in the first half of 2006.

ANA975 has been administered to more than 90 healthy volunteers in three completed phase 1 trials, setting the stage for the upcoming 28-day clinical study in hepatitis C infected patients.

Results from several clinical trials in hepatitis C patients receiving intravenous isatoribine for one week have demonstrated statistically significant and therapeutically relevant viral load reductions, officials said.

Data from the previous phase 1 trials of ANA975 in healthy volunteers indicate that the bioavailability of ANA975 is greater than 80% and conversion to isatoribine in plasma is rapid and effective, delivering levels of isatoribine that have been shown to be clinically relevant, officials said.

Anadys is a San Diego biopharmaceutical company focused on developing and commercializing novel small molecule medicines for the treatment of hepatitis, other serious infections and cancer.

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