BioKier has been awarded a $1.6 million Fast-Track 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), to support pre-clinical and clinical development of BioKier’s proprietary BKR-013 capsule for the management of blood glucose in diabetes patients. The grant will be awarded in two phases, Phase I for a toxicology study in dogs to determine safety of BKR-013 and Phase II to investigate efficacy in diabetes patients in a Phase 2a clinical study.
The two studies will provide the first data using BioKier’s oral formulation of L-glutamine, a capsule developed in collaboration with Encap Drug Delivery in Edinburgh and Professor Abdul Basit of University College of London. The project will be led by Principal Investigator Dr. George Szewczyk and will include collaboration with Dr. John Dillberger, who will oversee the toxicology study at MPI Research, located in Mattawan, Michigan, and Dr. Kishore Gadde, who will direct the clinical study at Pennington Biomedical Research Center in Baton Rouge, Louisiana. Drs. David D’Alessio, Director Division of Endocrinology, Metabolism, and Nutrition, Duke University, and Adrian Vella, Mayo Clinic Metabolomics Resource Core, Mayo Clinic, will provide expert consulting on clinical research in diabetes.
The project aims to establish safety of BKR-013 in the preclinical phase and will test efficacy in lowering average daily blood glucose, appetite, and serum triglycerides in type 2 diabetes patients in the clinical phase. The manufacture of BKR-013 capsules is expected to be completed in Q4 2016 and the toxicology study is due to start in Q3 2016. The clinical study will follow on the toxicology study in early 2017. A demonstration of efficacy in the clinical study will support claims for the marketing of BKR-013 as a medical food and inform on design of follow-on studies to expand the label.
The National Institute of Diabetes and Digestive and Kidney Diseases participates in the Small Business Innovation Research and Small Business Technology Transfer (STTR) programs. These programs support innovative research conducted by small businesses that has the potential for commercialization.