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news.Idenix Pharmaceuticals has initiated a proof-of-concept study of IDX184, a liver-targeted nucleotide prodrug candidate for the treatment of hepatitis C virus under an investigational new drug application with the FDA. The study is evaluating IDX184 in treatment-naive hepatitis C genotype-1 infected patients.
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The proof-of-concept trial in hepatitis C virus (HCV)-infected patients is being conducted at multiple centers around the world. The trial design is a Phase I/II, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and antiviral activity of IDX184 in treatment-naive adult patients infected with chronic hepatitis C.
The study will evaluate four doses of IDX184, ranging from 25 to 100mg once-per-day, administered for three days. Each cohort of the study will evaluate 10 patients randomized eight to IDX184 and two to placebo.
Jean-Pierre Sommadossi, CEO of Idenix, said: We are very pleased with the progress that we have made in our hepatitis C discovery program in 2008, having successfully advanced IDX184 from investigational new drug (IND) to a proof-of-concept study, while simultaneously advancing two additional HCV discovery programs into IND-enabling preclinical studies.
As we work to finalize a partnership for our lead HIV drug candidate, our goal in 2009 is to become the first biopharmaceutical company with innovative drugs from three major classes of direct-acting hepatitis C antivirals in clinical development.