Idenix Pharmaceuticals, Inc. (IDIX) announced that its nucleotide polymerase inhibitor candidate, IDX21437, showed potent antiviral activity in patients suffering from hepatitis C virus (:HCV) infection. IDX21437 was well-tolerated in 44 patients infected with HCV genotype (GT) 1, 2 or 3, who did not receive any treatment previously.
The proof-of-concept portion of the phase I/II study evaluated IDX21437 (50 mg, 150 mg or 300 mg) for 7 days in GT 2 and 3 patients and GT 1 patients (who also received placebo). Potent pan-genotypic activity was observed in patients administered with 300 mg of IDX21437.
Idenix confirmed its plans to start an all-oral pan-genotypic phase II combination study on IDX21437 (300 mg dose) and samatasvir (with and without ribavirin) for the treatment of HCV infection. The study is slated to start in mid-2014 and will enroll 200−300 patients. Pivotal studies on the combination are expected to commence in 2015.
We note that Idenix and partner Janssen are conducting a phase II study (HELIX−2) on samatasvir in combination with Olysio and TMC647055/r (with and without ribavirin) for GT 1 HCV infection.
Manwhile, Idenix started patient enrolment in the healthy volunteer portion of a phase I study on a follow-on uridine-based nucleotide prodrug candidate, IDX21459. The study will evaluate IDX21459 (once-daily doses in the range of 10 mg−300 mg) in 50 healthy volunteers for the treatment of HCV.
We are encouraged by the progress of Idenix in developing its HCV candidates. We expect investor focus to remain on pipeline updates from the company.
Currently approved drugs for HCV infection include Gilead Sciences Inc.’s (GILD) Sovaldi and Janssen’s Olysio. Gilead is also developing a once-daily fixed-dose combination of ledipasvir (:LDV) and Sovaldi for the treatment of chronic HCV genotype 1 infection.
Idenix currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Alkermes plc (ALKS) and Alexion Pharmaceuticals, Inc. (ALXN). Both stocks carry a Zacks Rank #1 (Strong Buy).