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NeoMatrix Announces Positive Topline Phase 1 Data for NMT-cP12

- Novel Peptide to Advance to Phase 2 for the Treatment of Severe Burns -

NEW YORK, September 24, 2020 (PRNewsire) – NeoMatrix Therapeutics, Inc., a clinical-stage company focused on developing a portfolio of novel, bioactive peptides with important potential for the treatment of burns and other types of tissue injury, today announced positive topline data from its Phase 1 clinical trial of NMT-cP12, its lead candidate for the treatment of severe burns.

The Phase 1 clinical trial included five escalating dose cohorts of eight healthy volunteers each, that either received one intravenous dose of NMT-cP12 or a control (normal saline). NMT-cP12 was safe and well-tolerated in the five cohorts, reaching up to eight-fold higher than the optimal dose identified in preclinical studies. Adverse events were dose-related mild to moderate pruritis experienced by two subjects in the top two dose cohorts and moderate urticaria in the highest dose cohort. No serious adverse events occurred in any subject.

The optimal dose predicted by preclinical animal studies gave blood levels for up to 2 hours at concentrations that, in small animals, induced microvascular dilation. In large animal burn models, these concentrations markedly decreased microvascular occlusion with aggregated red blood cells around burns, associated with improved wound healing and decreased scarring. These preclinical findings suggest that NMT-cP12’s pharmacologic activity may include a novel mechanism of action with promising potential for the treatment of burns and other types of tissue injury. Importantly in this context, no central cardiovascular effects were observed in the treated volunteers in the Phase 1 trial.

“The results from this clinical trial mark an important first step in the clinical development of NMT-cP12, which has the potential to significantly change both how we treat burns and the quality of life of burn patients,” said Richard A. Clark, M.D., founder and President of NeoMatrix Therapeutics. "The safety and pharmacokinetic data clearly support the further development of NMT-cP12. Based on these results, we have started designing a Phase 2 clinical trial, which is expected to launch in 2021, while actively exploring financing opportunities and strategic collaborations to accelerate the development of NMT-cP12 for severe burns."

About NMT-cP12

NeoMatrix Therapeutics’ NMT-cP12 is a small peptide derived from the naturally occurring 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 deeper layers of the skin. The extent of progression after the initial burn determines the need for surgery and the extent of consequential scarring and disfigurement from serious burns. NMT-cP12 has the potential to be a first-in-class treatment that could significantly improve patient outcomes by decreasing hospitalization time and the extent of post-burn disability, thus increasing the potential for burn victims to return to full function.

About NeoMatrix Therapeutics, Inc.

NeoMatrix Therapeutics is a clinical-stage company dedicated to developing novel, bioactive peptides that prevent injury progression and thereby rescue tissue and speed healing. Our portfolio of novel peptides was discovered by our founder, President, and Chief Scientific Officer, Richard A. Clark, M.D., also Professor of Dermatology, Biomedical Engineering, and Medicine at Stony Brook University. To date, our burn program has received over $12M in non-dilutive funding from the Armed Forces Institute of Regenerative Medicine (AFIRM), the Joint Warfighter Medical Research Program (JWMRP), and the Military Burn Research Program (MBRP).

Our lead candidates focus on the treatment of severe burns and have the potential to significantly improve the quality of life and clinical outcomes of burn patients by limiting injury progression following the initial burn. This shortens healing time and reduces scarring. Continuing tissue destruction following an initial injury is a problematic phenomenon that occurs in many types of conditions that involve progressive tissue injury, giving our novel peptides the potential to be used in multiple settings other than burns.

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About the Funding Awards

This work was/is supported by (i) the Assistant Secretary of Defense for Health Affairs, through the Defense Medical Research and Development Program (DMRDP) under Award Number W81XWH-20-1-0874, (ii) the U.S. Army Medical Research and Development Command (USAMRDC), through the Congressionally Directed Medical Research Programs (CDMRP) via the JWMRP under Award Number W81XWH-15-C-0043, and (iii) the U.S. Army Medical Research and Development Command (USAMRDC), through the MBRP under Award Number W81XWH-18-2-0059.

The views expressed in this release are those of the company and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

Safe Harbor

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995 and are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties, many of which are outside of our control.

There can be no guarantees that our pipeline products will receive the necessary regulatory approvals or be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks and uncertainties include, among others, our limited operating history, limited cash and a history of losses; our ability to obtain adequate financing to fund our operations; potential setbacks in our research and development efforts including negative or inconclusive results from our preclinical studies, our ability to secure required U.S. Food and Drug Administration or other approvals for our product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including COVID-19, including on our operations and clinical trials; our ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates; negative or inconclusive results from our clinical trials or serious and unexpected drug-related side effects or other safety issues experienced by participants in our clinical trials; and delays; and changes in regulatory requirements, policy and guidelines. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.


Richard A. Clark, M.D., President & Chief Scientific Officer

Peter F. Young, Interim Chief Executive Officer


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