Project Grant R43GM149096

A RECOMBINANT ELASTIN SKIN SUBSTITUTE FOR THE TREATMENT OF BURNS - PROJECT SUMMARY THE GOAL OF THIS PROJECT IS TO OPTIMIZE AND EVALUATE INSOMA BIO'S PROPRIETARY RECOMBINANT ELASTIN-BASED BIOMATERIAL, FRACTOMER, AS AN EFFECTIVE, LOW-COST SKIN GRAFTING SUPPORT MATRIX FOR THE TREATMENT OF SEVERE BURN WOUNDS. BURNS ARE MOST SUCCESSFULLY TREATED BY SURGICAL EXCISION FOLLOWED BY SKIN GRAFTING; HOWEVER MANY PATIENTS WITH SEVERE DAMAGE DO NOT HAVE SUFFICIENT HEALTHY SKIN TO SUPPORT AUTOGRAFT PROCEDURES. TO ADDRESS THIS NEED, BIOMATERIAL MATRICES, SUCH AS INTEGRA WOUND MATRIX, HAVE BEEN DEVELOPED WHICH REDUCE INFECTION, FACILITATE VASCULARIZATION, AND SUPPORT REGENERATION OF DERMIS TISSUE WHEN APPLIED TO BURN WOUNDS. THE CURRENT MARKET FOR DERMAL REPLACEMENT, VALUED AT OVER $7 BILLION, IS DOMINATED BY ANIMAL-DERIVED COLLAGEN DUE TO WELL ESTABLISHED PROCESSES FOR ISOLATING COLLAGEN FROM TISSUE AND HISTORICAL PRECEDENT FOR SAFETY. HOWEVER, DUE TO THE COST OF HARVEST FROM ANIMALS, THEY ARE NOTORIOUSLY EXPENSIVE, WITH A SINGLE 40 CM2 SHEET OF INTEGRA COSTING THE PATIENT ~$10K. IN ADDITION, COLLAGEN CANNOT REPLICATE THE ELASTICITY OF NATURAL SKIN, WITH ELASTIN, NOT COLLAGEN, PROVIDING SKIN WITH ITS RESILIENT AND PLIABLE PROPERTIES. AS ELASTIN PRODUCTION ALL BUT HALTS IN ADULTHOOD, CONTRACTION DUE TO LACK OF ELASTIN LEADS TO SCARING IN NEWLY DEVELOPED SKIN. AS A RESULT, AT LEAST ONE THIRD OF BURN TREATMENTS USING THESE MATERIALS REQUIRE SURGICAL REVISION. INSOMA'S FRACTOMER BIOMATERIAL IS MADE FROM RECOMBINANT ELASTIN-MIMETIC PROTEINS AND REPRESENTS AN IDEAL SUBSTRATE FOR THE PRODUCTION OF NEW SKIN GRAFTING MATRICES WHICH BETTER REPLICATE THE UNIQUE BIOMECHANICAL PROPERTIES OF SKIN. THE MATERIAL HAS BEEN SHOWN TO SUPPORT IN VIVO CELLULAR INFILTRATION, ORGANIZED COLLAGEN DEPOSITION, VASCULARIZATION, AND BIOCOMPATIBILITY DURING IN VIVO TESTING IN BOTH MURINE AND PORCINE MODELS AND, DUE TO ITS TEMPERATURE-SENSITIVE PHASE TRANSITION PROPERTIES, CAN BE READILY MOLDED INTO VIRTUALLY ANY FORM INCLUDING SKIN-LIKE SHEETS. DURING THE PHASE I PROGRAM PROPOSED HERE, THE COMPANY WILL CONTINUE OPTIMIZING FRACTOMER SHEET STRUCTURE AND FORMATION METHODS TO PRODUCE A MATERIAL WHICH SUPPORTS DERMAL REGENERATION THROUGH VASCULARIZATION, CELLULAR INFILTRATION, AND ORGANIZED COLLAGEN DEPOSITION. A PORCINE MODEL OF BURN WOUNDS WILL BE USED TO COMPARE FRACTOMER TO INTEGRA WOUND MATRIX, THE CURRENT GOLD STANDARD IN SKIN GRAFTING SUPPORT MATRICES. THE EXPECTED IMPROVEMENT IN GRAFT OUTCOMES (E.G., FEWER CONTRACTIONS AND NO OUTRIGHT REJECTIONS) BY EMPLOYING THE ELASTIN-BASED FRACTOMER GRAFT MATERIAL REPRESENTS A HIGHLY DISRUPTIVE PRODUCT TO THE CURRENT DERMAL REPAIR MATRIX MARKET.