Our Approach

Bariatric surgery (e.g., “Roux-En-Y bypass) now called metabolic surgery, performed for weight loss, shifts digestion of food from the upper small intestine to the lower part of small intestine and consequently improves type 1 diabetes and resolves type 2 diabetes within days in a majority of patients with diabetes. In addition, lowering of cholesterol, blood pressure, triglycerides, and C-reactive protein has been observed in these patients prior to significant weight loss (Buchwald, H. et.al; JAMA, 2004; 292:1724-1737). These effects have led to bariatric surgery being commonly referred to as bariatric-metabolic surgery. There is strong evidence that the mechanism of this effect results from expedited delivery of specific nutrients to the lower gut that promote secretion of gut hormones crucial for the regulation of blood glucose and lipids. BioKier’s approach is to deliver an active nutrient to the lower gut via a tablet, thus mimicking bariatric-metabolic surgery and promoting secretion of gut hormones with the need for surgery. 

BioKier is seeking a partnership with a consumer health or pharmaceutical company for commercialization and marketing.  A partnership is needed to complete clinical trials required to support label claims of this non-prescription product. Funds will be used to optimize the manufacturing processes and conduct additional clinical trials to expand our label claims demonstrating effectiveness in diabetes, hypercholesterolemia, and patients with both diseases.

The following animation shows:

  1. Nutrients in food stimulate hormone responses in non-diabetic subjects
  2. Diabetes affects this response
  3. RYGB corrects the effects of diabetes
  4. Targeted delivery of BioKier’s capsule will mimic the effects of RYGB
  5. Progress in product development and initial clinical results
  6. New grants and upcoming clinical trials

BioKier has devised several proprietary oral formulations with two active ingredients:

Butyrate Tablet:

BKR-017 (sustained-release)

Glutamine Capsule:

BKR-013 (rapid-release)

Release of L-glutamine and butyrate from coated capsules and tablets in simulated colonic environment.
Figure 2: Release of L-glutamine and butyrate from coated capsules and tablets in simulated colonic environment.  L-glutamine capsules were incubated in conditions mimicking stomach and small intestine (pre-colon) for 4 hours, and in conditions mimicking the colon for 12 hours (colon environment) (mean±SD, n=4).  Butyrate tablets were incubated in conditions mimicking stomach and small intestine (pre-colon) for 6 hours, and in conditions mimicking the colon for 10 hours (colon environment) (mean±SD, n=6).

All of these products are designed to mimic the effects of metabolic surgery and improve cardiometabolic health conditions such as hyperlipidemia (predominantly cholesterol), diabetes, and fatty liver without the physical trauma and cost of the surgery. BioKier’s approach is expected to be suitable for patients with high lipids, type 1 or type 2 diabetes, and fatty liver, both obese and non-obese. Specifically, the products act by stimulating L-cells in the lower gut, thus correcting the deficiency in secretion of endogenous gut hormones which is observed in diabetes, insulin resistance, and obesity. The gut hormones, which include GLP-1, PYY, GLP-2, and oxyntomodulin, regulate glucose metabolism, lipid levels, and appetite. Therefore, this treatment also is expected to have beneficial effects on hypertriglyceridemia, metabolic syndrome, and obesity.