STRP

Non-healing wounds are a serious complication of diabetes, affecting more than 6 million Americans annually. Despite their prevalence, effective treatment options remain limited, with few FDA-approved therapies offering meaningful benefits. A hallmark of diabetic wounds is excessive protease activity, which degrades structural proteins and impairs tissue regeneration. To address this unmet need, we are developing a novel therapeutic by repurposing Odanacatib, a selective small-molecule inhibitor of cathepsin K, a protease involved in the breakdown of the extracellular matrix. Originally developed for postmenopausal osteoporosis, Odanacatib has undergone extensive clinical evaluation, including Phase III trials [8, 9]. In our NIH-funded Phase-1 STTR studies, Odanacatib significantly improved healing outcomes in a clinically relevant diabetic porcine model, promoting re-epithelialization, collagen remodeling, and tissue regeneration. Building on these findings, this proposal aims to advance formulation development through the following objectives: (1) conduct customer discovery to assess the diabetic wound care landscape, unmet needs, and stakeholder priorities; (2) perform physicochemical characterization of the active pharmaceutical ingredient; (3) develop and validate analytical methods; and (4) conduct preliminary excipient compatibility studies.Following successful completion of this work, the next phase will focus on optimizing Odanacatib formulations and evaluating their performance through in vitro release, permeation testing, and stability studies. Lead candidates will undergo GLP preclinical safety evaluation and GMP scale-up to support a pre-IND meeting or IND submission. Odanacatib represents a first-in-class, locally administered therapy that targets the protease imbalance driving chronic wound pathology in diabetes.