Despite significant delays related to COVID-19, in late 2020 BioKier completed a 4-week study of BKR-017 in type 2 diabetes subjects. Dr. Kishore Gadde’s team at Pennington Biomedical Research Center (PBRC) successfully recruited and enrolled 14 subjects in the study. All of those subjects completed 4-week treatment. Data analysis is in progress and results will be known in Q1, 2021. In this study we focused on improvements in insulin sensitivity and cardiometabolic and inflammatory biomarkers. Results of this study will inform us about design of future studies with BKR-017 and provide data for labels claims for this product.
Simultaneously, BioKier, working with Emerson Pharmaceutical, completed GMP manufacturing of 100,000 BKR-017 tablets (50,00 active and 50,00 placebo) for the upcoming dose-response study. PCI Pharma Services has packaged the tablets in blister packs for randomized dosing in the study.
For the dose-response study BioKier is working with PBRC and Duke University Medical Center for executing this clinical trial. The trial will be conducted at PBRC, Baton Rouge, LA campus, as principal site, with Dr. Kishore Gadde as principle investigator and Duke Clinical & Translational Science Institute, as the second site, with Dr. Kristin Newby as principle investigator. In this 12-week, dose-response study we will randomize 80 type 2 diabetes subjects, who will be assigned to four, 20-person groups, receiving placebo or one of three doses. We will be measuring improvement in insulin sensitivity and changes in cardiometabolic and inflammatory biomarkers. This study will serve to determine lowest effective dose as well as claims for a product label. This study is expected to be completed in 12-15 months.