idenix pharmaceuticals inc (IDIX) Snapshot

Idenix Pharmaceuticals Inc. announced that it has appointed Charles Rowland to its Board of Directors. Mr. Rowland is Vice President and Chief Financial Officer of ViroPharma Incorporated. His appointment to the company's Board is effective immediately.

Idenix Pharmaceuticals Inc. announced the initiation of the phase II HELIX-1 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir (IDX719), Idenix's once-daily pan-genotypic NS5A inhibitor, and simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB. 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. Patients will be randomized equally across three treatment arms, receiving either 50, 100, or 150 mg samatasvir once-daily for 12 weeks in combination with simeprevir plus ribavirin. 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. SAMATASVIR (IDX719), 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. SIMEPREVIR (TMC435) is a once-daily potent investigational hepatitis C protease inhibitor in late phase III clinical development being jointly developed by Janssen R&D Ireland and Medivir AB to treat chronic hepatitis C virus infections. Simeprevir is being investigated in combination with PegIFN/RBV in phase III trials and is also being evaluated with direct-acting antiviral (DAA) agents in three other phase II interferon-free combinations both with and without ribavirin (RBV).

Idenix Pharmaceuticals Inc. Presents at UBS Global Healthcare Conference, May-21-2013 08:00 AM. Venue: Sheraton New York Hotel, 811 Seventh Avenue, New York, New York, United States. Speakers: Ronald C. Renaud, Chief Executive Officer, President and Director.