Mayo Clinic in Rochester MN working together with BioKier, Inc. have been awarded a $386,760 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 this project PI with Dr. George Szewczyk (BioKier, Inc.) 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 will be manufactured to support the clinical study. The tablets will be 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.
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 is expected to be completed in Q4, 2019. The clinical study will commence in early 2020 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. Market entry would be expected in Q2, 2022
JDRF is leading the fight against type 1 diabetes (T1D) 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 T1D.