Idenix Pharmaceuticals initiates Phase I/II hepatitis study

Posted on: Mon, 14 Jun 2010 13:10:37 EDT

(Datamonitor via COMTEX) --
Idenix Pharmaceuticals, a biopharmaceutical company, has initiated a Phase I/II, three-day proof-of-concept study of IDX320, a protease inhibitor for the treatment of hepatitis C virus, or HCV, infection, under a clinical trial application.

The study is evaluating IDX320 in treatment-naive hepatitis C genotype 1-infected patients. The proof-of-concept trial in HCV-infected patients is a Phase I/II randomized, parallel-arm, double-blind, placebo-controlled study evaluating the safety and antiviral activity of IDX320 in treatment-naive adult patients infected with chronic hepatitis C.

The study will evaluate four doses of IDX320, ranging from 50 to 400mg once-per-day, administered for three days. Each cohort of the study will evaluate eight patients randomized six to IDX320 and two to placebo.

Jean-Pierre Sommadossi, CEO of Idenix, said: "The potent and multi-genotypic activity demonstrated in vitro, as well as the favorable pharmacokinetics observed in healthy volunteers, suggests a promising profile for further development of IDX320. The landscape for combination development in HCV is evolving quickly. Assuming favorable results from the IDX320 proof-of-concept study, we plan to discuss with regulatory agencies a direct-acting antiviral combination strategy with IDX320 and IDX184, our HCV nucleotide polymerase inhibitor."

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