SBIR-STTR Award

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop the first non-invasive, device-based treatment for type 2 diabetes which mimics the therapeutic benefits of bariatric surgery. The proposed non-invasive intestinal lining temporarily alters signaling pathways in the small intestine to mimic the metabolic effects of bariatric surgery. The 27 million Americans and 300 million patients globally with type 2 diabetes are desperate for a treatment that reinstates glycemic control as opposed to current management strategies, such as metformin and insulin, which only slow the progression of the disease. The potential commercial impact of the treatment is significant as the total estimated cost of diagnosed diabetes in the US is upwards of $245 billion, and on the rise. Overall, an astounding 1 in 5 US health care dollars are used for the care of people with diabetes. Major insurers have expressed interest in the reimbursement of alternative approaches such as the one proposed, thereby lessening the national cost burden.The proposed project entails proof-of-concept experiments on the bench top and in-vivo animal model to address the most pertinent technological risks with the approach. The first specific aim is to develop and test several formulations of the intestinal lining and evaluate pertinent performance features. The second aim is to develop an ingestible delivery method of the selected lining for localized deployment. Consultation with leading endocrinologists, gastroenterologists, and material scientists regarding bariatric surgery has guided the selection of very specific delivery targets within the gastrointestinal tract. These targets form the success criteria for specific aim 2. The third and final specific aim is to determine if the lining can be delivered and remain functional in the small intestine for a period of 2 hours to modify nutrient absorption in a porcine model. This aim will provide proof-of-concept for the overall approach and motivate the NSF STTR phase 2 application, wherein more rigorous and long term safety and efficacy studies will be performed.

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.