Idenix has completed a three-day proof-of-concept study of IDX184. The company is developing IDX184, a novel liver-targeted prodrug of 2′-methyl guanosine nucleotide, for the treatment of Hepatitis C Virus (HCV).
This double-blind, placebo-controlled, monotherapy, dose-escalation study evaluated the safety and antiviral activity of IDX184.
In this study, 41 treatment-na ve HCV genotype-1-infected patients were randomized to receive either IDX184 or placebo once-daily for three days. Four dosing cohorts (25mg, 50mg, 75mg and 100mg) of IDX184 were evaluated.
In the 75 and 100mg/day cohorts, patients receiving IDX184 experienced improvements in two key markers of liver injury, with mean AST and ALT levels decreasing to below the upper limit of normal. These improvements were sustained for up to 6 days post-dosing, and most levels returned to baseline 14 days post-treatment.
Douglas Mayers, CMO of Idenix, said: We are pleased with the results of this study, which support the potential for IDX184 to be a best-in-class nucleoside/tide polymerase inhibitor with demonstrated antiviral activity and tolerability, coupled with a low once-daily dose.
Now that we have successfully completed the proof-of-concept study in HCV-infected patients, we plan to advance IDX184 into a 14-day dose-ranging study in combination with the current standard-of-care, pegylated interferon and ribavirin, to determine the optimal IDX184 doses to advance into broader clinical trials, he added.