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 is a fully human monoclonal antibody against NGF that was designed to reduce pain sensitization in neurons.
Preclinical experiments indicate that fasinumab specifically binds to NGF and blocks NGF activity, and that fasinumab 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 and other investigational agents against NGF on partial clinical hold in December 2012 due to reports of sympathetic nervous system toxicity in mature animals being treated with other anti-NGFs.
Fasinumab is no longer on clinical hold by the FDA. A Phase 2b/3 study in pain due to osteoarthritis initiated in mid-2015, and an additional Phase 3 trial of greater than 16 weeks is expected to begin in the first half of 2016.