STONY BROOK, N.Y.--(BUSINESS WIRE)--The Investigational New Drug Application (IND) filed by NeoMatrix Therapeutics, Inc.(www.neomatrixtx.com) for NMT-cP12 has gone into effect per the U.S. Food and Drug Administration (FDA). With this active IND, NeoMatrix becomes a clinical-stage company and will study NMT-cP12, a small peptide-drug candidate, being evaluated to limit the severity and resultant disabilities associated with serious burn injuries. NMT-cP12 has also previously received Orphan Drug Designation from the FDA.
NMT-cP12, a highly specific and highly engineered therapeutic derived from the protein fibronectin, is designed to target platelet-derived growth factor (PDGF), thereby promoting tissue cell survival and inhibiting the cascade of burn injury progression—a significant unmet need in burn patients.
According to Healthcare Cost and Utilization Project (HCUP), there were 53,220 hospital admissions in 2013 with costs averaging $24,000 per stay compared with $10,700 for all other stays. Currently available treatments for serious burn injuries are limited to surgery to remove damaged tissue, anti-infectives and pain management. The Company’s program to discover and develop NMT-cP12 has been built on approximately $10 million of funding from the NIH and Department of Defense, to date.
“Now that the IND application for NMT-cP12 has gone into effect, NeoMatrix Therapeutics has made the major transition to a clinical-stage company, after many years of research to engineer fibronectin into a highly targeted small peptide molecule. We plan to initiate a Phase 1 clinical trial to assess the safety and tolerability of this drug candidate in healthy volunteers as soon as possible,”said Richard A. Clark, M.D., founder and president of NeoMatrix Therapeutics. “If successful, NMT-cP12 would be a first-in-class treatment that may offer not only clinical benefits but also pharmacoeconomic benefits given the intense burn care that is required for burn victims. We are very excited to have reached this important milestone in our program to bring forward a desperately needed treatment for burn victims in both the military and civilian populations.”
NeoMatrix Therapeutics’ NMT-cP12 is a small peptide derived from the large and multi-functional protein fibronectin, which has been shown to play an important role in many biological processes, including wound healing. In preclinical studies using a validated animal model, NMT-cP12 demonstrated its ability to limit burn injury progression, the cascade of events by which the tissue damage from the initial burn spreads into the layers of the skin after the initial burn, by targeting platelet-derived growth factor (PDGF). The extent of progression of the initial burn determines the need for surgery and the extent of consequential scarring and disfigurement from serious burns. If successful, NMT-cP12 would be a first-in-class treatment that could significantly improve patient outcomes by decreasing times of hospitalization and the extent of post-burn disability, thus increasing the potential of burn victims to return to full function.
About NeoMatrix Therapeutics, Inc.
NeoMatrix Therapeutics, Inc. www.neomatrixtx.com is a clinical-stage company dedicated to discovering and developing novel therapeutic agents for the treatment of serious burn injuries. The Company was founded by Richard A. Clark, M.D., Professor of Dermatology, Biomedical Engineering, and Medicine at Stony Brook University, and has its headquarters in the Long Island High Tech Incubator on the campus of Stony Brook University.