Regeneron has been a leader in the discovery and characterization of a new class of proteins, called neurotrophins, which promote the growth of nerve cells. Members of this family of proteins include nerve growth factor (NGF), BDNF (brain-derived neurotrophic factor), NT-3, and NT-4/5. Our most advanced product candidate is fasinumab (REGN475), a fully-human antibody that specifically targets NGF.
Fasinumab (REGN475) is a fully human monoclonal antibody against NGF that was designed to reduce pain sensitization in neurons.
Preclinical experiments indicate that REGN475 specifically binds to NGF and blocks NGF activity, and that fasinumab (REGN475) does not bind to or block cell signaling for closely related neurotrophins (NT) such as NT-3, NT-4 or BDNF (brain-derived neurotrophic factor).
The U.S. Food and Drug Administration (FDA) placed fasinumab (REGN475) and other investigational agents against NGF on Clinical Hold in December 2010 after a case confirmed as avascular necrosis of a joint was seen in another company’s anti-NGF program. At that time, the FDA expressed concern that this case, which followed previously-reported cases of joint replacements in patients on an anti-NGF drug candidate being developed by a different pharmaceutical company, provides evidence to suggest a class effect. None of these effects have been observed with fasinumab (REGN475).
Fasinumab (REGN475) is currently on partial clinical hold by the FDA, limiting duration of trials in osteoarthritis to 16 weeks. A Phase 2b/3 study in pain due to osteoarthritis iniated in mid-2015.