Idenix Pharmaceuticals Presents Positive Preclinical Data on HCV Programs at The Annual Meeting of The European Association for the Study of the Liver (EASL) Wednesday April 23, 8:00 am ET
CAMBRIDGE, Mass., and MILAN, Italy, April 23 /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 and other infectious diseases, today announced preclinical data from the company's polymerase and protease inhibitor programs for the treatment of hepatitis C. These data are being presented at the Annual Meeting of the European Association for the Study of the Liver (EASL) being held this week in Milan, Italy.
Second-Generation Nucleoside Polymerase Inhibitor Program
IDX184 is a nucleotide prodrug derived from Idenix's proprietary liver- targeting technology. Results from in vitro and in vivo preclinical studies confirm that this technology preferentially activates IDX184 in the liver, potentially enhancing the antiviral activity of the drug and limiting systemic side effects. In an HCV replicon model, IDX184 exhibited 10 times greater potency than the first-generation HCV nucleoside clinical drug candidates currently in development. In HCV genotype-1 infected chimpanzees, once-daily oral administration of 10 mg/kg of IDX184 resulted in a mean viral load reduction of 2.3 log10 (n=5) after four days of dosing. No toxicities, including gastrointestinal or hematological, or abnormal blood chemistry were observed at oral doses greater than or equal to 600 mg/kg/day in a supporting seven-day toxicology study in cynomolgus monkeys.
IDX184 demonstrated additive antiviral activity in the HCV replicon in combination with HCV protease inhibitors and interferon and synergistic activity in combination with ribavirin. IDX184 also remained fully active in vitro against HCV containing known protease and non-nucleoside inhibitor drug resistance mutations.
Data from this program are being presented by David Standring, Ph.D., executive vice president, biology, Idenix Pharmaceuticals, in an oral presentation session at 5:30 p.m. CET on Friday, April 25, 2008, and by Erika Cretton-Scott, Ph.D., director, preclinical pharmacology at Idenix Pharmaceuticals, in a poster session beginning on Thursday, April 24, 2008.
Novel Macrocyclic Protease Inhibitor Program
Based on two novel macrocyclic scaffolds, Idenix has discovered compounds that demonstrated potency with subnanomolar antiviral activity against the HCV genotype 1b NS3/4A protease target and single nanomolar activity in the HCV replicon. These compounds also displayed high selectivity in vitro with no inhibition of selected human cellular proteases. In vitro, the Idenix protease inhibitors exhibited antiviral activity against certain HCV resistant mutants associated with first-generation protease inhibitors currently in clinical development. Pharmacokinetic studies demonstrated adequate oral bioavailability and sustained liver concentrations suggesting the potential for once-daily or twice-daily dosing. Data from this program are being presented by Dr. Standring in an oral presentation session at 6:15 p.m. CET on Thursday, April 24, 2008.
"The preclinical profiles emerging in our HCV nucleoside and protease inhibitor programs are very encouraging when compared to first-generation drug candidates from both of these drug classes," said David Standring, Ph.D., executive vice president, biology, of Idenix. "We plan to have product candidates from both of these programs in clinical development within the next 12 months with the goal to evaluate our own novel combinations thereafter."
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