CAMBRIDGE, Mass., Aug. 7, 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 second quarter ended June 30, 2013.
HCV Pipeline and Business Review
Samatasvir (IDX719), NS5A Inhibitor Program
- In May 2013, Idenix initiated the phase II HELIX-1 12-week 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. Treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients are enrolled in one of three treatment groups receiving 50, 100, or 150 mg samatasvir once-daily for 12 weeks in combination with simeprevir plus ribavirin.
- The first cohort of patients (n=29) has completed enrollment. The Data Safety Monitoring Board has reviewed all data relating to this cohort up to 28 days of treatment and recommended that the study continue enrollment, which is now underway.
- The treatment regimen has been well tolerated and there have been no treatment-related serious adverse events in the clinical trial to date.
- Rates of sustained virologic response measured four weeks after the end of treatment (SVR4) will be available for the first cohort of patients in the fourth quarter of 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 begin enrolling genotype 1 or 4 treatment-naïve HCV-infected patients in the third quarter of 2013.
- In June 2013, Idenix announced a request from the United States Food and Drug Administration (FDA) for additional preclinical safety information for IDX20963, Idenix's lead uridine nucleotide prodrug candidate. Pending potential resolution of this request, the initiation of clinical testing of IDX20963 in the U.S. is on hold. Idenix has supplemental preclinical work ongoing and is compiling data to respond to the FDA's communication. The Company is simultaneously pursuing a clinical development strategy for IDX20963 outside the U.S.
- Additionally, Idenix plans to file a regulatory submission to initiate clinical trials for a second uridine nucleotide prodrug inhibitor in the second half of 2013.