CAMBRIDGE, Mass., Jan. 12 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced that it has initiated a proof-of-concept study of IDX184, a liver-targeted nucleotide prodrug candidate for the treatment of HCV under an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA). The study is evaluating IDX184 in treatment-naive hepatitis C genotype-1 infected patients.
"We are very pleased with the progress that we have made in our hepatitis C discovery program in 2008, having successfully advanced IDX184 from IND to a proof-of-concept study, while simultaneously advancing two additional HCV discovery programs into IND-enabling preclinical studies," said Jean-Pierre Sommadossi, Ph.D., chief executive officer of Idenix. "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."
The proof-of-concept trial in 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 100 mg once-per-day, administered for three days. Each cohort of the study will evaluate ten patients randomized eight to IDX184 and two to placebo.
IDX184 is a once-daily, oral nucleotide prodrug candidate based on Idenix's proprietary li
|SOURCE Idenix Pharmaceuticals, Inc.|
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