NeoMatrix Announces Positive Topline Phase 1 Data for NMT-cP12

NeoMatrix Therapeutics 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."

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.