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.
| NEW YORK, Sept. 24, 2020 /PRNewswire/ -- 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 About NeoMatrix Therapeutics, Inc. 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. To learn more, visit: www.neomatrixtx.com. About the Funding Awards 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 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. Contact:
SOURCE NeoMatrix Therapeutics, Inc. |
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