Idenix Pharmaceuticals, Inc.
) 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.
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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.
) 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
Alexion Pharmaceuticals, Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).