Idenix Pharmaceuticals Reports Data From Three Hepatitis C Development Programs at the 44th Annual Meeting of the European Association for the Study of...(m a pharmacokinetic/pharmacodynamic (PK/...)

Date:4/23/2009

m a pharmacokinetic/pharmacodynamic (PK/PD) relationship between nucleoside metabolite concentrations in serum and viral load reductions in this study. Trough serum nucleoside metabolite levels were low, ranging from 2-8 ng/mL, and there was a direct correlation between levels of NM and HCV RNA, with greater viral load reductions observed as the NM levels increased. Specifically, serum trough NM levels of greater than 2 ng/mL were associated with HCV RNA reductions of 1 log10 or greater.

An additional presentation on IDX184 detailed results of the double-blind, placebo-controlled, single dose-escalation study that evaluated the safety and pharmacokinetics of IDX184 in healthy volunteers. Eight subjects (randomized 6:2, active:placebo) in each dosing cohort were administered a single dose of IDX184, ranging from 5 mg to 100 mg, or placebo. IDX184 was safe and well-tolerated in this study; the most common adverse event reported was dizziness and it was more frequently reported in subjects receiving placebo. In this study, the pharmacokinetics of IDX184 and the nucleoside metabolite were consistent with a liver-targeted drug. Systemic exposures and plasma half-life of the nucleoside metabolite were similar to that of its active triphosphate measured in vitro in human hepatocytes. In this healthy volunteer study, IDX184 doses of 50 mg/day and higher led to serum NM levels greater than 2 ng/mL 24 hours post-dose.

A phase I/II proof-of-concept clinical trial of IDX184 in treatment-naive HCV genotype-1 patients is ongoing.

IDX316 Protease Inhibitor

IDX316 exhibited potent activity against HCV NS3/4A proteases from multiple genotypes (1a, 1b, 2a and 4a) and in HCV replicons. Long-term in vitro treatment (14 days) with IDX316 produced high levels of suppression that was maintained over the treatment period without evidence of rebound or cytotoxicity. IDX316 also demonstrated high selecti
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