Antimicrobial Treatment to Combat Wound Biofilm

Over 6.5 million US patients suffer from chronic wounds. Even though nearly $50 billion is invested in treatments annually, approximately 30% of patients will not heal using existing interventions and many wounds progress to serious infections, with some leading to amputation or death. Recent studies show over 75% of chronic wounds harbor biofilms, and mounting evidence indicates these are a critical barrier to successful treatment. Current products used to manage wound bioburden are not effective against biofilm and they can cause irritation and cytotoxicity that impairs healing. New therapeutics are needed that are effective against bacteria in biofilms and conducive to healing. The goal of this project is to develop a new generation of wound treatments based on a novel antimicrobial peptide formulated in a biocompatible and biodegradable wound management matrix. The product, called Gatekeeper™, has demonstrated efficacy against biofilms and is significantly more biocompatible than commonly used silver and chlorhexidine. The easy to apply product forms a hydrogel that maintains a moist wound healing environment and ensures intimate contact with the wound bed to effectively kill bacteria and prevent biofilm recurrence. Gatekeeper™’s broad spectrum activity against biofilms of multidrug resistant bacteria has been demonstrated in vitro, ex vivo and in both small and large animal models of infected wounds. The lead peptide has been selected, the formulation has been optimized, and substantial work has been completed that identified key requirements for production, packaging, and sterilization. The product is stable to end stage sterilization and has demonstrated 2-year real time stability at room temperature. The scope of the proposed project covers transition of the current lab scale production to pilot manufacturing under cGMP, production of cGMP product inventory to support verification and validation (V&V) testing, completion of V&V testing, including non-clinical safety studies, and assembly of the product’s design history file and device master record to prepare for an FDA filing for product clearance. Gatekeeper™ is expected to have a substantial impact on advancing treatment options for chronic wound patients. It will improve quality of life by reducing infection, odor, pain, and time to healing. Because the cost of wound care scales with time to wound closure and complications associated with infection, the proposed product also has potential to reduce treatment costs.