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www.fdanews.com/articles/85538-idenix-provides-update-on-clinical-development-of-valopicitabine

IDENIX PROVIDES UPDATE ON CLINICAL DEVELOPMENT OF VALOPICITABINE

March 24, 2006

Idenix Pharmaceuticals has given an update on its clinical development program for valopicitabine (NM283) for the treatment of hepatitis C. The company has modified its ongoing Phase IIb clinical trials to reduce valopicitabine dosing levels from 800 mg/day to 200 mg/day or 400 mg/day as a result of dose-related gastrointestinal side-effects observed in both treatment-naive and treatment-refractory patients receiving 800 mg dose regimens of valopicitabine.

The original protocol for the ongoing 48-week clinical trial included five randomized treatment arms, all involving dosing regimens of valopicitabine, administered once-daily, in combination with pegylated interferon alfa-2a (Pegasys) 180 ug per week.