The Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH) has awarded Biodel Inc. a grant for the development of novel and stable glucagon formulations for use in an artificial pancreas, also known as a closed loop pump system.
The Small Business Innovation Research (SBIR) program is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization.
Biodel’s two-year grant, totaling $582,763 is intended to fund research to develop proprietary glucagon product candidate optimized to algorithmically deliver glucagon as part of a bihormonal closed loop system to mitigate hypoglycemic events. Currently the full benefits of intensive insulin therapy for patients with diabetes have yet to be realized in large part because it is extremely difficult to optimize continuously variable insulin dose requirements using current technology and because of the inability to eliminate hypoglycemia. The use of glucagon to blunt the glucose lowering effects of excess insulin may enhance the feasibility of fully automated artificial pancreas systems, thereby minimizing the occurrence of hypoglycemia. Currently marketed formulations of glucagon are chemically and physically unstable in solution at high temperatures and are not likely to be practical for infusion through insulin pumps. Biodel will pursue a strategy to develop a stable glucagon formulation suitable for pump delivery.