BioKier has been awarded a $436 K Phase I Small Business Innovation Research (SBIR) Grant by The National Heart, Lung, And Blood Institute (NHLBI), an institute of The National Institutes of Health (NIH). The grant funded submission of an Investigational New Drug (IND) application to FDA to allow the conduct of clinical study designed to determine changes of butyrate in plasma after single dose and repeated dose administration of BKR-017. The active ingredient in BKR-017 is butyrate and is formulated in a colon-targeted, sustained-release, tablet administered orally. This formulation is designed to mimic the mechanism through which gastric bypass surgery improves or resolves diabetes and initiates weight loss.
BioKier is conducting the clinical study at Pennington Biomedical Research Center (PBRC) in collaboration with Dr. Frank Greenway. The participants enrolled in the study will be hypercholesterolemic patients unable to control their LDL cholesterol levels. Results of this study will demonstrate the effect on systemic concentrations of butyrate in a relevant patient population. It is expected that butyrate plasma concentrations measured after oral administration of BRK-017 will not exceed the concentrations that have been reported as safe in the literature and will, therefore, provide additional data to support the safe administration of BKR-017
These data are critical to support further development.
Successful completion of this study will enable BioKier to apply for Phase II SBIR grant, which will fund optimization of the drug product formulation, drug production scale-up, and clinical studies with the optimized colon-targeted butyrate drug product formulation (BKR-019) in a hypecholesterolemic population.
NHLBI participates in the SBIR and Small Business Technology Transfer (STTR) programs. These programs support innovative research conducted by small businesses that have the potential for commercialization.