Idenix (IDIX) Announces Presentations of IDx184 at AASLD in Boston
Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) today announced presentations of data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine (2'MeG) for the treatment of HCV, at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) currently being held in Boston, Massachusetts.
Data from a three-day, phase I proof-of-concept study evaluating the safety and antiviral activity of IDX184 will be presented. This double-blind, placebo-controlled, monotherapy, dose-escalation study enrolled 41 treatment-naive HCV genotype 1-infected patients into four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg). IDX184 was well tolerated in this study with no serious adverse events reported and no discontinuations from the study. Patterns of adverse events (AEs) were similar between IDX184- and placebo-treated patients with the most frequent AEs being headache, diarrhea and dizziness. Mean viral load declines ranged from 0.47 log10 in the 25 mg group to 0.74 log10 in the 100 mg group after three days of treatment. In the 75 and 100 mg/day cohorts, patients receiving IDX184 experienced improvements in two key markers of liver injury (AST and ALT), with mean levels of these enzymes decreasing to within normal range. Pharmacokinetic data demonstrated that higher plasma levels of 2'MeG were associated with greater reductions in viral load and ALT levels.
IDX184 is a novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing.
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