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CAMBRIDGE, Mass., June 6, 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 announced three poster presentations featuring clinical and preclinical data for samatasvir (IDX719), Idenix's once-daily pan-genotypic NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection, at the Asian Pacific Association for the Study of the Liver (APASL) Liver Week 2013, taking place in Singapore, June 6-10, 2013. Idenix recently initiated a phase II clinical trial (HELIX-1) evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir and simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB.
The following abstracts will be presented in poster sessions during APASL Liver Week 2013 in the Conference Exhibition Hall on Friday, June 7, 2013, 8:30am - 5:30pm SGT:
Abstract No. 2110: "Pharmacokinetics and Pharmacodynamics of IDX719, a Pan-Genotypic HCV NS5A Inhibitor, in Genotype 1, 2, 3 or 4 HCV-Infected Subjects."
Abstract No. 2121: "Hepatitis C Virus NS5A Inhibitor IDX719 Demonstrates Potent, Pan-genotypic Activity in Preclinical and Clinical Studies."
Abstract No. 2127: "IDX719, a Pan-genotypic HCV NS5A Replication Complex Inhibitor, Is a Promising Candidate for HCV Combination DAA Treatment."
ABOUT SAMATASVIR (IDX719)
Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity
in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers for up to 14 days' duration and up to 100 mg in HCV-infected patients up to 3 days' duration. There have been no treatment-emergent serious adverse events reported in the program. Samatasvir has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients with mean maximal viral load reductions up to approximately 4.0 log
10 IU/mL across HCV genotypes 1-4 in a proof-of-concept, three-day monotherapy study.
The HELIX-1 trial is a 12-week, randomized, double-blind, parallel group study evaluating the safety and tolerability of samatasvir and simeprevir in addition to antiviral activity endpoints, with a target enrollment of 90 treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients. The HELIX-1 trial is the first study in HCV-infected patients to commence under a non-exclusive collaboration agreement signed with Janssen in January 2013. A second trial (HELIX-2) of samatasvir, simeprevir and TMC647055, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen, is expected to initiate in the second half of 2013.