FDAnews
www.fdanews.com/articles/72849-idenix-completes-enrollment-of-valopicitabine-phase-iib-trial

Idenix Completes Enrollment of Valopicitabine Phase IIb Trial

May 31, 2005

Idenix Pharmaceuticals has completed enrollment of its Phase IIb clinical trial of valopicitabine (NM283) with more than 170 treatment refractory hepatitis C genotype 1 patients.

Valopicitabine is being evaluated in patients who have previously failed treatment with pegylated interferon plus ribavirin. This six-month, head-to-head trial, comparing the combination of valopicitabine plus Pegasys to ribavirin plus Pegasys, is evaluating more than 170 hepatitis C genotype 1 patients who have previously failed at least three months of treatment with pegylated interferon plus ribavirin, the current standard therapy.

Idenix expects to report initial clinical data from this Phase IIb trial in the fall of 2005. Currently, the company anticipates initiating a Phase III clinical trial in this patient population in the first half of 2006.