(R)-ND-336 for the Treatment of Diabetic Foot Ulcers
Abstract
Diabetes affects more than 30 million individuals in the United States. Approximately 25% of Veterans receiving care from the Department of Veterans Affairs (VA) have diabetes. A common complication of diabetes is the inability of wounds to heal, typically occurring in the foot and referred to as diabetic foot ulcers (DFUs). DFUs affect one in four diabetic patients. The standard-of-care is the periodic surgical removal of dead tissue from the wound and reducing pressure on the foot to improve healing, and treatment of wound infection with antibiotics. There is a single U.S. Food and Drug Administration (FDA)-approved drug called becaplermin; however, it is seldom used because of increased risk of cancer and death. The lack of effective therapies results in over 100,000 lower-limb amputations annually in the United States. The prognosis after an amputation is poor with a 1-year mortality of 44%. There is an urgent need to develop new drugs for treatment for DFUs. This project addresses the Diabetes Topic Area: Research on interventions to treat diabetes complications, including impaired wound healing. We have identified an enzyme in diabetic wounds that is the reason why diabetic wounds do not heal; the culprit factor. We have discovered a new topical drug named (R)-ND-336 that inhibits/neutralizes the activity of the detrimental enzyme. (R)-ND-336 speeds up healing of wounds in diabetic mice faster than becaplermin. This project proposes to complete studies to show that (R)-ND-336 is safe to enter human clinical trials. The proposed research will advance (R)-ND-336 to clinical trials for the treatment of DFUs with potential life-changing consequences for patients. (R)-ND-336 is a first-in-class drug with a new and previously unexplored mechanism of action, which will have a profound impact for patients suffering for DFUs. (R)-ND-336 is not a palliative drug and actually addresses the pathological basis of DFUs as a disease, in a manner that is unprecedented.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910493
Entities
People
- Mayland Chang
Organizations
- United States Army
- University of Notre Dame