Posted March 2, 2022

Richard Clark, M.D., NeoMatrix Formulations, Inc.

Burns are dynamic injuries that evolve over time in terms of depth and size of the burns. The burn research community describes this concept, burn wound conversion, as a cascade of events following the initial burn injury, specifically when superficial partial-thickness burns evolve to deep partial-thickness or full-thickness burns. The dynamic nature of burn wound conversion leads to treatment challenges, with patients frequently requiring multiple surgeries, skin grafting, longer hospital stays, and lengthy rehabilitation, along with pain, scarring, and other long-term complications that affect burn survivors.

The Military Burn Research Program (MBRP) seeks to fund research that advances novel products focused on arresting burn wound conversion. The MBRP issued a Fiscal Year 2017 Clinical Trial Award to Dr. Richard Clark and his team at NeoMatrix Therapeutics, Inc. to advance the development of a novel peptide drug called cP12, which the team demonstrated in a relevant animal model of burns to limit progressive tissue damage and promote burn wound closure when administered by intravenous (IV) infusion within 1-4 hours of the burn injury. cP12 is a novel peptide drug derived from fibronectin, a naturally occurring protein involved in tissue healing and regeneration. Fibronectin degrades following a burn injury, and burn patients show low levels of the protein in blood and other bodily fluids. The clinical award funded the team to complete a randomized, double-blind, placebo-controlled phase 1 single ascending dose study to evaluate the safety, tolerability, dosing, and pharmacokinetics of cP12 in healthy individuals. Thirty healthy adults completed the trial with no serious adverse events observed. The investigators concluded that cP12 was well-tolerated in adults at the clinically effective optimal dose. NeoMatrix is currently designing a phase 2a clinical trial to evaluate the safety and efficacy of cP12 in patients admitted to burn centers with 5% to 20% total body surface area burns. The Food and Drug Administration (FDA) has granted cP12 Orphan Drug status as well as �Fast Track� designation, a process intended to expedite review of drugs that treat a serious condition with little to no available treatments. Preclinical work on P12-related peptides, including cP12, was originally funded through the Armed Forces Institute of Regenerative Medicine.

In addition to the MBRP-funded award, the Combat Readiness Medical Research Program (CRRP) awarded NeoMatrix a Fiscal Year 2019 Rapid Development and Translational Research Award for preclinical work on another fibronectin-derived peptide drug named cNP8. When faced with prolonged field care and delayed treatment beyond the 4-hour window for delivery of cP12, cNP8 may be given up to 24 hours after burn injury to prevent burn wound progression. The anticipated preclinical animal data derived from the CRRP-funded award will facilitate submission of an Investigational New Drug application to the FDA for cNP8 clinical safety and efficacy testing.

With limited treatment options available for preventing burn wound conversion, the novel drugs cP12 and cNP8 could significantly reduce burn complications for the patient and ease the burden of clinical care associated with deep-partial and full-thickness burns.

Links:

Public and Technical Abstracts: A Phase 1 Randomized, Placebo-Controlled, Single Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of cP12 in Healthy Adults

IND-Enabling Studies for Scalable Peptide Therapy to Limit Burn Conversion and Speed Wound Closure

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