BioKier has been awarded a $3.0 million Phase IIb Small Business Innovation Research (SBIR) Grant by The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), an institute of The National Institutes of Health (NIH). The grant will fund $1 million per year for three years to support manufacturing and clinical development of BioKier’s proprietary BKR-017, to evaluate the improvement of insulin sensitivity and triglyceride levels in diabetes patients. BKR-017 is composed of butyrate formulated in a colon-targeted, sustained-release, tablet administered orally, and is designed to mimic the mechanism through which gastric bypass surgery improves or resolves diabetes and initiates weight loss.
The grant will support two clinical studies in type 2 diabetes. In the first, BioKier will conduct a clinical trial at Pennington Biomedical Research Center (PBRC) in collaboration with Dr. Kishore Gaddy. As a follow-on, a second larger and longer 12-week, multi-site dose-response study will be conducted to determine the effective dose for commercialization. This trial will be conducted at three clinical centers with PBRC, led by Dr Kishore Gaddy, serving as primary site. Dr. David D’Alessio, Director Division of Endocrinology, Metabolism, and Nutrition, Duke University, will provide expert consulting on clinical research in diabetes.
The project’s aim is to demonstrate safety and efficacy of BKR-017 in type 2 diabetes patients in the clinical phase. The manufacture of BKR-017 tablets is expected to be completed in Q4 2019. The first clinical trial will commence in early 2020. The dose-response clinical trial is targeted to begin in Q4, 2020 and will support claims and dose selection for the marketing of BKR-017 as a medical food or supplement.
The National Institute of Diabetes and Digestive and Kidney Diseases participates in the SBIR and Small Business Technology Transfer (STTR) programs. These programs support innovative research conducted by small businesses that has the potential for commercialization.