October 31, 2017 07:15 AM Eastern Daylight Time - Press Release
NeoMatrix Therapeutics Enters Clinical Stage as Investigational
New Drug Application for NMT-cP12 Goes Into Effect
Potential First-in-Class Peptide Treatment for Serious Burn Injuries Targets PDGF
STONY BROOK, N.Y. - The Investigational New Drug Application (IND) filed by NeoMatrix Therapeutics, Inc. 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. <Read More>
NeoMatrix Therapeutics, Inc. 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. NMT has its headquarters in the Long Island High Tech Incubator on the campus of Stony Brook University.
lead product candidate
NeoMatrix’s NMT-cP12 is a small peptide derived from the large and multi-functional protein fibronectin that has shown in research to play an important role in many biological processes, including wound healing. In preclinical studies using a developed and validated animal model, NMT-cP12 demonstrated its ability to limit burn injury progression, the cascade of events by which the tissue damage from an initial burn spreads into layers of 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 extent of post-burn disability, thus increasing the potential of burn victims to return to full function.
cP12 is a first-in-class treatment that could significantly improve patient outcomes by decreasing times of hospitalization and extent of post-burn disability, thus increasing the potential of burn victims to return to full function.
regulatory status of cp12
Active Investigational New Drug
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. NeoMatrix filed its IND application for cP12 in August, 2017. The application was reviewed by the FDA and became "Active" in September, 2017. FDA
Orphan Drug status
The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemption and 7-year marketing exclusivity upon FDA approval. FDA
Meets criterion for Fast Track Designation
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. FDA
Clinical stage company built with ~$10 Million of NIH and DoD funding to date.