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Idenix Pharmaceuticals Advances HCV Discovery Program to Clinic
Date:7/29/2008

antiviral activity in both in vitro and in vivo preclinical models. Pre-clinical testing suggests that this technology enables the delivery of high levels of active nucleoside triphosphate into the liver, the site of primary HCV infection. In HCV genotype-1 infected chimpanzees, once-daily oral administration of 10 mg/kg of IDX184 produced a mean viral load reduction of 2.3 log10 after four days of dosing.

"The in vitro antiviral activity of IDX184 combined with the marked viral load reductions observed in HCV-infected chimpanzees support the potential for once-a-day, low milligram dosing of IDX184 in HCV-infected patients," said David Standring, Ph.D., executive vice president of biology for Idenix.

The company has initiated a first-in-man study of IDX184 under a U.S. IND. The study design is a double-blind, placebo-controlled, single dose-escalation study to evaluate the safety and pharmacokinetic activity of IDX184 in healthy volunteers. This study will evaluate six single rising doses of IDX184, ranging from 5 mg to 100 mg once-per-day. Each cohort of the study will evaluate eight volunteers randomized six to IDX184 and two to placebo. This study will be followed by a phase I/II proof-of-concept study in treatment/naive, HCV genotype-1 infected patients.

IDX375 Non-Nucleoside Polymerase Inhibitor

Idenix has selected IDX375 as its lead clinical candidate from its HCV non-nucleoside polymerase inhibitor discovery program. Preclinical testing demonstrated that IDX375 targets the palm non-nucleoside pocket of HCV polymerase. IDX375 has exhibited single nanomolar in vitro potency against HCV genotype 1b replicon (EC50 = 2 nM) and against HCV genotype 1a and 1b polymerases. Additionally, cellular cytotoxicity testing in Huh-7 cells demonstrated that IDX375 is not cytotoxic (CC50 >100 micrometers), resulting in a selectivity index >33,000 for IDX375. In preclinical in vitro studies, IDX375 did not inhibit human cellular DNA polymerases alph
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SOURCE Idenix Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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