Idenix Pharmaceuticals ($IDIX) announces initial data from phase I clinical trial of IDX719

Idenix Pharmaceuticals NASDAQ: IDIX) is engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.

• IDX719 is an an NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection
• In the first part of the study, eight healthy volunteers received 100 mg of IDX719 daily for seven days. All doses were well tolerated and pharmacokinetic data supports once-daily dosing in future studies.
• In the second part of the study, single-ascending doses of IDX719 achieved substantial viral load reductions in the following cohorts of HCV-infected patients:
  • A cohort of 12 HCV genotype 1-infected patients received single IDX719 doses of 1, 5, 10, 25, 50 or 100 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log10, 2.6 log10, 3.3 log10, 3.7 log10, 2.8 log10 and 3.5 log10, respectively;
  • A cohort of three HCV genotype 2-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 0.4 log10, 3.2 log10 and 3.5 log10, respectively; and
  • A cohort of three HCV genotype 3-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 2.2 log10, 3.7 log10 and 3.3 log10, respectively.
• A three-day proof-of-concept study has initiated dosing and is designed to evaluate 64 treatment-naïve genotype 1, 2, 3 or 4 HCV-infected patients.
• Additionally, Idenix has completed enrollment of the second cohort of 30 patients in the ongoing 12-week phase IIb study of IDX184. IDX184 continues to be safe and well tolerated with no treatment-emergent serious adverse events reported and a side effect profile similar to that of PegIFN/RBV. Further data from the ongoing clinical trial will be available in H2.

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