Granexin Gel to Treat Pressure Ulcers
Abstract
In the last 20 years, hospitals and long-term care facilities have dedicated significant effort to preventing pressure ulcers (PrUs) with the implementation of pressure offloading devices and weight-shifting programs. Despite these efforts, PrUs remain a major health concern in the U.S., affecting nearly 3 million people. Because most PrUs are open wounds, individuals with PrUs are at high risk for life-threatening infections. Approximately 60,000 deaths in the U.S. every year are due to complications associated with PrUs. PrUs, also referred to as skin sores, decubitus ulcers, or bedsores, occur due to prolonged local pressure in one area of the skin, where changes in circulation occur as a direct result of sitting or lying in the same position for extended periods of time. PrUs commonly occur on bony regions such as elbows, shoulders, heels, or the back of the head, and pressure on these regions for as little as 2 hours can initiate tissue damage that leads to PrUs. PrUs are one of the most common and costly complications that occur following injuries that limit mobility such as spinal cord injury (SCI), traumatic brain injury (TBI), and limb amputation. Annual cost of PrUs for a single patient can exceed $100,000. On the battlefield, active-duty Service Members seriously injured during combat are often subjected to extended periods of immobilization while awaiting medical transport or evacuation. Soldiers suffering from SCI or TBI are secured to vacuum spine boards or North Atlantic Treaty Organization (NATO) litters while awaiting evacuation from theater, and these devices are known to contribute to PrU development. PrUs significantly complicate definitive care for these patients that are often suffering from complex polytraumatic injuries. The outlined proposal is directly responsive to FY20 PRMRP Focus Area of PrUs with emphasis on the Areas of Encouragement: “Novel strategies for the treatment of pressure ulcers, including the mitigation of progression to advanced stages” and “Development of novel wound healing strategies.” In a Phase 2 efficacy and safety trial, FirstString will evaluate the therapeutic potential of a topical gel, Granexin, in mitigating PrU progression and promoting PrU healing. Standard of care for PrUs has not changed in decades and primarily consists of standard wound care practices including cleaning, dressing changes, and debridement. Currently, there are no FDA-approved therapeutics that promote healing at the molecular/cellular level and prevent PrU progression. The transmembrane protein connexin43 (Cx43) has well-defined roles in inflammation and wound healing. FirstString Research has bioengineered a cell-permeable peptide-therapeutic that modulates Cx43 signaling and has shown therapeutic potential in the treatment of chronic wounds when administered in a stable topical formulation (Granexin). Granexin has advanced through extensive preclinical and clinical development, with statistically significant and clinically meaningful outcomes in the treatment of acute and complex skin wounds. Successful Phase 2 clinical trials have validated the efficacy of Granexin in promoting healing of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), complex wounds with underlying pathophysiology that parallels that of PrUs. Across all four completed clinical trials, Granexin has not been associated with any adverse events or immunogenicity. Preclinical and clinical results demonstrating Granexin efficacy in promoting wound closure strongly support completion of this Phase 2 clinical trial evaluating Granexin efficacy in mitigating PrU progression and promoting PrU healing. Granexin has the potential to serve as a ready-to-use standard of care for the treatment of PrUs at points of intervention ranging from pre-hospital to definitive care environments. Granexin is a CONOPS friendly, safe, stable, easy-to-use topical gel that can be easily retained and transported for point-of-care delivery at
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110416
Entities
People
- Christina Grek
Organizations
- FirstString Research (United States)
- United States Army