SBIR Phase II: Orally-dosed Intestinal Coating for the Treatment of Type 2 Diabetes Inspired from Bariatric Surgery

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project addresses the healthcare needs of the 27 million Americans and 300 million patients globally suffering with type 2 diabetes (T2D). These patients are desperate for a safe treatment that reestablishes glycemic control to augment or replace current management strategies such as metformin and insulin, which only slow the progression of the disease. This proposal provides a unique approach to T2D based on an orally delivered intestinal coating that mimics the beneficial metabolic effects of bariatric surgery. The potential commercial impact of this novel treatment is highly significant as the total estimated cost of diabetes management in the US is upwards of $245 billion, and rising. Overall, an astounding 1 in 5 US health care dollars is used for the care of people with diabetes. Therefore, major insurers are very interested in the reimbursement of alternative approaches for treating T2D, thereby lessening the national cost burden. The proposed project supports the further development of an entirely novel treatment for T2D based on new insights from bariatric surgery. The medical community has recently recognized that certain bariatric procedures involving duodenal exclusion confer profound and immediate benefits in glucose tolerance. Sleeve-type medical devices have provided clinical validation for this approach, but such devices are invasive and not currently approved due to safety issues. The investigators propose a non-invasive and safe orally-delivered intestinal coating which is expected to provide the same effect as surgery and implanted sleeves, but requires neither a specialist nor sedation. This proposal describes in-vitro and in-vivo experiments that build on positive results of the Phase I project, and drive the company towards human clinical trials. Specific Aim-1 is to optimize the active lead compound through evaluation of a limited number of rational structural variations. Specific Aim 2 is to demonstrate the dose-dependent efficacy and safety of lead formulations in a chronic diabetic animal model. Consultation with leading endocrinologists, gastroenterologists, and material scientists has guided the selection of the materials and methods of this proposal. Completion of the studies outlined in the NSF SBIR Phase II proposal will accelerate clinical translation, bringing this novel treatment closer to patients in need.