Novel dermal templates for prevention and treatment of biofilms in cutaneous wounds

PROJECT SUMMARY The goal of this Phase II SBIR proposal is to further develop an anti-biofilm, peptide-based, tissue- scaffolding matrix, G4B, for preventing and eliminating biofilms from acute and chronic wounds. Fifteen percent of the 347M diabetic patients worldwide will develop a foot ulcer1–3, of which 56% will become infected4–6 and lead to chronic wounds. Approximately 60-78% of chronic wounds and 6% of acute wounds contain microbial biofilms 7,8. Biofilms are a significant cause of persistent infections associated with prolonged inflammation, failure to re-epithelialize, and responsiveness to wound management, all contributing to impaired and delayed wound healing7,10,11. Currently, available wound care products show limited efficacy in promoting infection-free wound closure as they: (i) lack effective antimicrobial agents, (ii) do not sufficiently promote healing, and (iii) semi-rigid membrane sheets fail to conform to the entire wound bed. As a result, these products leave dead spaces where bacteria and biofilms can persist, compromising wound healing and increasing the risk of infection. The proposed G4B membrane conforms closely to the wound bed, ensuring full coverage and leaving no dead space where bacteria and biofilms could persist. G4B is a self- assembled peptide matrix membrane with preliminary and published data showing: i) antimicrobial activity against a broad spectrum of MDROs34–38, including prevention and treatment of biofilms; ii) scaffolding properties for promoting cell attachment and proliferation in wounds, and iii) a durable but flexible and highly wound conforming membrane format. To prepare G4B for FDA-enabling studies, we propose to: Aim 1) optimize G4B formulations based on physician user feedback, mechanical properties, and confirmatory antibiofilm and cytocompatibility testing, Aim 2) conduct in vivo testing of SA1 formulations to confirm G4B safety and efficacy, Aim 3) demonstrate the feasibility of manufacturing G4B, including sterile packaging, and Aim 4) hold a Pre-Submission meeting with the FDA to validate the planned 510(k) regulatory strategy. Gel4Med has a strong track record of turning NIH investment into patient outcomes, securing FDA clearance through our development of our first product, G4Derm, that also utilizes peptide biomaterials to improve wound care. With Phase II SBIR funds, Gel4Med will develop a membrane-based, antibiofilm product to improve healing and limb preservation for chronic wound patients. Following the successful completion of the proposed work, G4B will be ready for FDA-enabling GLP studies and a 510(k) submission.