BioKier Inc. is an early-stage pharmaceutical company developing new proprietary medical foods and drugs for diabetes and related disorders. BioKier has identified a therapeutic opportunity and is developing a novel oral product for type 2 diabetes. This oral capsule will potentially also have effects in metabolic syndrome and obesity.
Not only are the markets for these metabolic conditions extremely large and growing, but the approved treatments, which include prescription drugs and modifications of diet, are not fully effective and in many cases have adverse side effects. BioKier’s approach encompasses a proprietary formulation for targeted delivery of active nutrient compounds that are known to be safe in humans. BioKier has demonstrated proof of the concept in animal models that its compounds can have a dramatic effect on diabetes when delivered orally and has clinical proof of the principle that its compounds are active in diabetes patients.
The active ingredient of BioKier’s lead product, L-glutamine, is a natural compound abundant in food. L-glutamine has been shown to be the most active and potent natural gut hormone secretagogue acting on colorectal L-cells. However in individuals with diabetes and insulin resistance, nutrients such as L-glutamine are primarily absorbed earlier and do not reach the colon and rectum in sufficient quantities to stimulate a full L-cell response. Unless its delivery bypasses the absorptive upper gut and reaches its site of action in the colon, oral L-glutamine is ineffective as a gut hormone secretagogue and glucoregulator. BioKier’s formulation is designed to deliver L-glutamine to the colon.
Because L-glutamine is a natural compound abundant in food and the formulation components for the product are GRAS (Generally Regarded As Safe), BioKier plans to initially develop the product for use as a medical food. Medical foods are specially formulated products for the dietary management of a disorder, disease, or condition that has distinctive nutritional needs and cannot be met by normal diet alone and are used in patients under the care of a physician. These criteria were defined in the FDA’s 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal, Drug, and Cosmetic Act. Medical foods are not subject to the FDA drug approval process. Thus BioKier’s product could see a product launch as early as within 18-24 months.
Developing and launching BioKier’s product as a medical food will not preclude the company from developing the product as a prescription pharmaceutical at a later date.