Idenix valopicitabine to start Phase III in ’06
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Idenix hopes to finalize a Phase III trial protocol for its hepatitis C agent valopicitabine by March 2006, the firm says Dec. 2. FDA requested additional data from a Phase IIb trial during a Nov. 30 end-of-Phase II meeting; Idenix plans to submit the data in January. "Valopicitabine is an orally bioavailable pro-drug of a novel ribonucleoside analog, and is an inhibitor of HCV and related viruses," Idenix says. The company has other antivirals in development, including valtorcitabine and telbivudine, both for hepatitis B. A telbivudine NDA is slated for submission before year-end...