Idenix Pharmaceuticals reports positive data from Phase I hepatitis trial

Tue. November 03, 2009; Posted: 07:02 AM

Nov 03, 2009 (Datamonitor via COMTEX) -- IDIX | Quote | Chart | News | PowerRating -- Idenix Pharmaceuticals, a biopharmaceutical company, has reported positive data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine for the treatment of hepatitis C virus, or HCV.

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 (25mg, 50mg, 75mg and 100mg). IDX184 was well tolerated in this study with no serious adverse events reported and no discontinuations from the study.

Mean viral load declines ranged from 0.47 log10 in the 25mg group to 0.74 log10 in the 100mg group after three days of treatment. In the 75 and 100mg/day cohorts, patients receiving IDX184 experienced improvements in two key markers of liver injury, with mean levels of these enzymes decreasing to within normal range. Pharmacokinetic data demonstrated that higher plasma levels of 2'-methyl guanosine were associated with greater reductions in viral load and ALT levels.

David Standring, executive vice president of biology of Idenix, said: "The in vitro combination data for IDX184 are promising. We look forward to assessing this potential synergy in the next clinical study evaluating IDX184 in combination with pegylated interferon and ribavirin in HCV genotype 1-infected patients."

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