Regeneron’s anti-NGF mAb meets Phase II/III endpoint

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Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said fasinumab (REGN475) met the primary endpoint of significantly improving pain relief vs. placebo in a Phase II/III study to treat moderate to severe osteoarthritis (OA) pain of the hip or knee. The study enrolled 421 patients with a history of inadequate pain relief or intolerance to current analgesic therapies.

Through week 16, Regeneron said the overall incidence of adverse events was similar across the fasinumab and placebo groups, but there was an increase in some neuro-musculoskeletal adverse events in the fasinumab groups (17% combined for all doses vs. 6% for placebo). Regeneron did not respond to an inquiry about a partial clinical hold FDA had placed on fasinumab.

Two other anti-NGF mAbs are also in late-stage studies to treat pain: tanezumab (PF-4383119) jointly owned by Pfizer Inc. (NYSE:PFE) and Eli Lilly and Co. (NYSE:LLY) and fulranumab (AMG403), owned by Amgen Inc. (NYSE:AMGE).

Full article available at BioCentury.