Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
CAMBRIDGE, Mass., July 20 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has successfully completed a three-day proof-of-concept study of IDX184. Idenix is developing IDX184, a novel liver-targeted prodrug of 2'-methyl guanosine nucleotide, for the treatment of HCV.
This double-blind, placebo-controlled, monotherapy, dose-escalation study evaluated the safety and antiviral activity of IDX184. In this study, 41 treatment-naive HCV genotype-1-infected patients were randomized to receive either IDX184 or placebo once-daily for three days. Four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg) of IDX184 were evaluated. IDX184 was well tolerated in this study with no serious adverse events reported and no discontinuations from the study. Patterns of adverse events were similar between IDX184- and placebo-treated patients. Viral load declines were observed in 30 of the 31 IDX184-treated patients, with no response in one patient in the 25 mg cohort. Significant viral load reductions were observed in the three higher dose cohorts (50, 75 and 100 mg/day). Post-treatment viral load data suggest no evidence of drug accumulation. The table below summarizes mean HCV RNA reductions observed in this study per cohort:
End of Treatment Mean Patients with 1 log10 or
Change in HCV RNA Greater Reduction in HCV
Cohort Dose (log10) RNA at End of Treatment
------ ---- --------------------- --------------------------
A (n=6*) 25 mg/day -0.47 1
------- ------------ ----- ---
B (n=8) 50 mg/day -0.69 1
------ ------------ ----- ---
C (n=8) 75 mg/day -0.70 2
------ ------------ ----- ---
D (n=9) 100 mg/day -0.74 4
------ ------------ ----- ---
Control Placebo
(n=8) +0.01 0
* Eight subjects were randomized to this cohort, two of whom were excluded
from the viral load evaluation due to an error in dosing.
"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," said Douglas Mayers, M.D., chief medical officer of Idenix. "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."
In the 75 and 100 mg/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.
"We have made great progress in our HCV discovery and development programs this year," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "With the successful completion of the proof-of-concept study for IDX184 and plans to file investigational new drug applications in the coming months from our non-nucleoside polymerase inhibitor and protease inhibitor programs, we are closer to achieving our ultimate goal of developing novel combinations of direct-acting antivirals for the treatment of hepatitis C."
The company plans to report the full data set from this study at a scientific meeting later this year.
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