In collaboration with Mayo Clinic in Rochester MN, BioKier has been awarded a $500K SRA Grant by JDRF (formerly known as the Juvenile Diabetes Research Foundation) to conduct a study in Type 1 Diabetes Patients. Adrian Vella MD (Mayo Clinic, Rochester, MN) will be the Principal Investigator on this project, with Dr. George Szewczyk (BioKier) as co-PI. The study will support clinical development of BioKier’s proprietary BKR-017, colon-targeted, sustained-release butyrate tablets, to evaluate the effect on improvement of insulin sensitivity and triglyceride levels in type 1 diabetes patients. The grant will be conducted in two phases. During phase 1, tablets of BKR-017 were manufactured to support the clinical study. The tablets were manufactured by Emerson Resources, Inc., BioKier’s manufacturing partner. In phase 2, Dr Adrian Vella will conduct a 12-week clinical trial of BKR-017 at the Mayo Clinic in type 1 diabetes patients.
ClinicalTrials.gov Identifier: NCT03999853
The aim of the clinical trial is to demonstrate safety and efficacy of BKR-017 in type 1 diabetes patients. The manufacture of BKR-017 tablets was completed in 2019. The clinical study will commence in early 2023 and will be conducted as a 12-week (4 weeks of run-in and 8 weeks of treatment) open-label study and will test the effect of BKR-017 on patients’ insulin sensitivity, triglyceride levels, and glucose variability. Positive results in this study will support commercialization of the product.
JDRF is leading the fight against type 1 diabetes by funding research, advocating for policies that accelerate access to new therapies and providing a support network for millions of people around the world impacted by type 1 diabetes.