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news.After a meeting with the FDA, Idenix Pharmaceuticals has said that it anticipates finalizing the study design for a phase III clinical trial of its hepatitis C candidate, valopicitabine, in treatment-refractory patients by the end of the first quarter of 2006.
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At the meeting, the FDA requested additional information from the two ongoing phase IIb clinical trials evaluating valopicitabine. In response, Idenix plans to provide the FDA with comprehensive 24-week data from the ongoing phase IIb clinical trial in treatment-refractory patients.
The company also expects to provide initial data from the ongoing phase IIb trial evaluating valopicitabine in treatment-naive patients, which includes a patient cohort receiving valopicitabine 800mg plus pegylated interferon beginning on day one of treatment. This is the treatment regimen that the company currently expects may be evaluated in phase III clinical trials.
The company anticipates that it will provide in January 2006 the further data that have been requested and thereafter meet with the FDA. At that meeting, the company anticipates further discussing with the FDA the proposed phase III clinical trial protocol.
“We are pleased with the interaction we have had with the FDA to date regarding valopicitabine development,” said Jean-Pierre Sommadossi, CEO of Idenix. “We are optimistic that we will continue to advance the valopicitabine clinical program, particularly in view of the serious unmet need in the treatment-refractory patient population in hepatitis C.”