NeoMatrix Therapeutics: cP12 (IV Therapy)

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NMT- cP12 is a novel, bioactive peptide for intravenous treatment of burns within 2 to 4 hours of injury.  NMT- cP12 has the potential to limit burn injury progression, shorten healing time, and reduce scarring of deep or extensive burns in hospitalized patients.

 

FDA has granted NMT-cP12 Orphan and Fast Track Designation for severe burns.

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NMT-cP12 is a novel Fibronectin (FN) derived, 14-mer peptide (P12) from the first FN type III repeat that promotes mesenchymal cell growth, proliferation and migration in vitro and acts synergistically with a variety of growth factors including platelet-derived growth factor-BB. FN has been shown to play a vital role in wound healing and is deficient in burn patients’ wounds and blood. P12 protects adult human dermal fibroblasts from cell death induced by oxidative and cytokine stress in vitro. In addition, blood vessel occlusion in burns is well-known and results in impaired oxygenation and ultimately tissue necrosis in the peri-burn tissue.  NMT-cP12 has been demonstrated in animal models to vasodilate the microvasculature and to reduce blood vessel occlusion.  Thereby, a single infusion of NMT-cP12 limits burn injury progression, speeds healing and reduces scarring in a porcine burn model.

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Phase 1 Results

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A Phase 1 ascending dose study of NMT-cP12 was completed in 2020 in 30 healthy volunteers. NMT-cP12 was safe and well-tolerated up to eight-fold higher than the optimal dose identified in preclinical studies and no related or unrelated serious adverse events occurred during the trial.

 

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Development Plans

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NeoMatrix is currently designing a Phase 2a study to assess the safety and efficacy of cP12 in patients with 5-20% total body surface area burns. The study is expected to begin in the first half of 2021.    

 

References:

Lin F, et al., J Invest Dermatol, 131:84-98, 2011.

Ohashi T, et al., J of Invest Dermatol, 134(4), 882-884, 2013. 

Lin F, et al., J Invest Dermatol, 134:1119-1127, 2014.

Zhu J, et al., J Invest Dermatol, 134:921-929, 2014.

Asif B, et al., Wd Rep Regen, 24:501-513, 2016.

Frame MD, et al., Microcirculation 24:24:e12369, 2017.

Clark RAF, et al., Exp Dermatol, 27:625-629, 2018.

Lin K, et al., J of Invest Dermatol, 138(11), 2480-2483, 2018.