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Idenix Pharmaceuticals Reports Third Quarter And Nine Month 2013 Financial Results And Provides HCV Pipeline Update

Stocks in this article: IDIX

-- Enrollment initiated for a phase I/II clinical trial for IDX21437, a next-generation uridine nucleotide prodrug inhibitor for the treatment of hepatitis C virus infection (HCV) -- Initiation planned for HELIX-2 combination study in collaboration with Janssen Pharmaceuticals, Inc. including pan-genotypic HCV NS5A inhibitor, samatasvir -- Idenix to host conference call / webcast at 4:30 p.m. ET today

CAMBRIDGE, Mass., Oct. 30, 2013 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the third quarter ended September 30, 2013.

HCV Pipeline Review

Nucleotide Inhibitor Program

  • IDX21437, a next-generation uridine nucleotide prodrug inhibitor, has received approval to enter clinical trials in Canada and Belgium. Idenix has initiated enrollment for the healthy volunteer portion of a phase I/II clinical trial. Extensive preclinical testing for IDX21437 demonstrated favorable antiviral activity across genotypes 1-6 and a safety profile which supported advancement into clinical trials.
  • Idenix is conducting additional preclinical work as requested by the United States Food and Drug Administration for IDX20963, a uridine nucleotide prodrug candidate.

Samatasvir (IDX719), NS5A Inhibitor Program

  • All patients (n=63) have completed enrollment in Part A of the phase II 12-week HELIX-1 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir, Idenix's once-daily pan-genotypic NS5A inhibitor, and simeprevir, a once-daily NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and ribavirin in treatment-naive, non-cirrhotic, genotype 1b or 4 HCV-infected patients. SVR4 data for patients in Part A of the study are anticipated to be available in the fourth quarter of 2013. Part B of the ongoing HELIX-1 clinical trial includes exploratory cohorts which have been added to evaluate the safety and antiviral activity of a 25 mg dose of samatasvir in genotype 1b-infected patients and of a 100 mg dose of samatasvir in genotype 6-infected patients.
  • Idenix is planning to initiate a second 12-week phase II clinical trial in collaboration with Janssen Pharmaceuticals, Inc., HELIX-2, which will evaluate the 3-DAA combination of samatasvir, simeprevir and TMC647055, a once-daily NS5B non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen R&D Ireland, with and without ribavirin in genotype 1-infected patients who are either treatment-naive or have previously relapsed after treatment with pegylated interferon and ribavirin.

"A key objective for our development teams has been to commence a clinical trial for our nucleotide prodrug program this year," said Ron Renaud, Idenix's President and Chief Executive Officer. "Based on the differentiated profile we've seen in our preclinical research, we believe IDX21437 has strong potential to be a key component of a fixed-dose all-oral pan-genotypic regimen, specifically in combination therapy with our NS5A inhibitor."

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