Evaluation of a novel connexin-based peptide for the treatment of diabetic wounds

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DESCRIPTION (provided by applicant): According to the American Diabetes Association, there are more than 16 million people in the United States with known diabetes. Diabetic patients commonly demonstrate impaired wound healing. Approximately 20 percent of patients with diabetes will develop foot ulceration in their lifetime. Diabetic foot ulceration (DFU) represents a major problem that can significantly impair the patient's quality of life, require prolonged hospitalization, and may involve infection, gangrene, and amputation. It has been estimated that for each new foot ulcer the attributable cost for a middle-aged diabetic man in the first two years is approximately $ 30,000. The cost of DFU to the healthcare system is over one billion dollars per year in the United States. A well- established reason as to why diabetic wounds are tough to heal is that they do not progress through the normal healing phases. Instead, it is thought that diabetic wounds are caught and remain trapped in the initial inflammatory phase of wound healing. FirstString Research, Inc. (FSR) is a biotech company located in Charleston, South Carolina. The founders of FSR, Drs. Robert Gourdie and Gautam Ghatnekar are co inventors of a class of novel bioengineered peptides - we refer to as ACT peptides. Based on our data from treatment of acute wounds as well as preliminary data from wound healing in diabetic C57BL/KsJ-m+/+Leptdb (db+/db+) mice, we believe that our lead compound, ACT1 peptide will have beneficial effects in the treatment of chronic wounds such as DFU's. ACT1 peptide has been shown to significantly dampen down the initial inflammatory response and promote faster and effective progression through wound healing. We hypothesize that ACT1 peptide will provide a unique, mechanistically based approach to restoring normal progression of wound healing in diabetics. Milestones for Phase I project: 1. To determine whether or not ACT1 peptide promotes wound healing, and reduces inflammation in diabetic C57BL/KsJ-m+/+Leptdb (db+/db+) mice. 2. To determine if topically applied ACT1 peptide on skin wounds in diabetic C57BL/KsJ-m+/+Leptdb (db+/db+) mice has any systemic effects as evaluated by blood analyses and necropsy. Present therapies and drugs for wound healing in diabetes and chronic wounds in general are predominantly symptomatic, empirical, unpredictable, and largely ineffective The ACT1 peptide potentially offers a mechanistically based solution to not just faster wound closure but also significant cost savings and more importantly improving the quality of life in diabetic patients. The development of FSR's ACT1 peptide via milestones outlined in this SBIR, not only will meet this specific need for patients and surgeons, but also has the potential to lay a platform for broader clinical applications and commercial opportunities.