Key Developments For Idenix Pharmaceuticals, Inc.
Idenix Pharmaceuticals, Inc. (IDIX.O) (Consolidated Issue listed on NASDAQ Global Market)
Idenix Pharmaceuticals, Inc. Initiates Phase II Clinical Trial Of IDX184 In Combination With Pegylated Interferon And Ribavirin For Treatment Of Hepatitis C Virus (HCV)
Idenix Pharmaceuticals, Inc. announced that it has initiated a Phase II clinical trial evaluating IDX184, a liver-targeted nucleotide prodrug candidate for the treatment of HCV, in combination with pegylated interferon and ribavirin, in treatment-naive hepatitis C genotype 1-infected patients. Antiviral activity, safety and tolerability of the triple combination will be assessed at 14 days. Patients will continue on treatment with pegylated interferon and ribavirin for 14 days and Rapid Viral Response (RVR), the proportion of patients with undetectable virus at week 4, will be determined at Day 28.The clinical trial is a Phase II, randomized, double-blind, placebo-controlled, sequential dose-escalation study evaluating the safety, tolerability, pharmacokinetics and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve HCV genotype 1-infected patients. Patients will receive a daily dose of IDX184 or placebo plus pegylated interferon and ribavirin for 14 days and then continue on pegylated interferon and ribavirin for an additional 14 days. Antiviral activity will be assessed at the 14-day and 28-day timepoints. All patients in the study will have the option to continue pegylated interferon and ribavirin for up to 48 weeks. Four doses of IDX184 ranging from 50 to 200 mg per day will be evaluated. Each cohort of the study will evaluate twenty patients randomized 16 to IDX184 and 4 to placebo.
Idenix Pharmaceuticals, Inc. Announces Data on IDX184 for Treatment of Hepatitis C Virus (HCV)
Idenix Pharmaceuticals, Inc. announced presentations of data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine (2'MeG) for the treatment of HCV, at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) held in Boston, Massachusetts. 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 (25 mg, 50 mg, 75 mg and 100 mg). IDX184 was well tolerated in this study with no serious adverse events reported and no discontinuations from the study. Patterns of adverse events (AEs) were similar between IDX184- and placebo-treated patients with the most frequent AEs being headache, diarrhea and dizziness. Mean viral load declines ranged from 0.47 log10 in the 25 mg group to 0.74 log10 in the 100 mg group after three days of treatment. In the 75 and 100 mg/day cohorts, patients receiving IDX184 experienced improvements in two key markers of liver injury (AST and ALT), with mean levels of these enzymes decreasing to within normal range. Pharmacokinetic data demonstrated that higher plasma levels of 2'MeG were associated with greater reductions in viral load and ALT levels.
Idenix Pharmaceuticals, Inc. Says Novartis AG Not To License Hepatitis C Drug-Reuters
Reuters reported that Idenix Pharmaceuticals, Inc. said Novartis AG has decided not to exercise its option to license Idenix's hepatitis C drug, sending Idenix shares down. Idenix said it will continue to develop the drug, IDX184, and will seek a new partner.
Idenix Pharmaceuticals, Inc. Prices Underwritten Offering of Common Stock
Idenix Pharmaceuticals, Inc. announced the pricing of an underwritten offering of 7,248,936 shares of its common stock at a price of $3.14 per share. After underwriting discounts and commissions and estimated offering expenses, the Company expects to receive net proceeds of approximately $21.2 million. All of the shares are being sold by Idenix. The offering is expected to close on August 10, 2009, subject to customary closing conditions. Leerink Swann LLC is acting as sole book-running manager for the offering.
Idenix Pharmaceuticals, Inc. Completes Proof Of Concept Study Of IDX184 For Treatment Of Hepatitis C Virus (HCV)
Idenix Pharmaceuticals, Inc. announced that it has completed a three-day proof-of-concept study of IDX184. The Company is developing IDX184, a 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. 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.
