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ARTICLE | Clinical News

Regeneron, Teva’s anti-NGF mAb meets 16-week endpoints in Phase III for OA pain

August 17, 2018 5:24 PM UTC

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said fasinumab met the co-primary endpoints at week 16 in a substudy of the larger Phase III FACT LTS & OA trial to treat chronic pain caused by osteoarthritis of the knee or hip. Fasinumab is a mAb against nerve growth factor (NGF).

The substudy included 646 patients who received placebo or 1 mg subcutaneous fasinumab every eight weeks or every four weeks. The substudy is part of a larger trial that includes 52 weeks of active treatment in about 3,500 patients to evaluate the long-term safety of the candidate. The primary efficacy analysis is at week 16, and the primary safety analysis for the larger trial will occur at week 72. Full safety data are expected in 2021...