BioKier Inc.
BioKier is a clinical-stage pharmaceutical company developing oral products designed to mimic the effects of bariatric-metabolic surgery, aiming to improve the management of diabetes and related metabolic disorders. Their innovative formulations target the lower gut to stimulate gut hormone secretion, thereby regulating glucose and lipids, with the goal of changing how diabetes is managed worldwide.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Sustained-release colon-targeted butyrate tablet
Oral sustained-release tablet formulation engineered to resist gastric and small-intestinal transit and release butyrate in the colon over several hours to stimulate colonic L-cell hormone secretion.
Colon-targeted L-glutamine capsule
Capsule formulation delivering L-glutamine to the colon to stimulate L-cell secretion of GLP-1 and other gut hormones; developed as a rapid-release colon-targeted capsule for metabolic modulation.
Sustained-release colon-targeted butyrate tablet
Oral sustained-release tablet formulation engineered to resist gastric and small-intestinal transit and release butyrate in the colon over several hours to stimulate colonic L-cell hormone secretion.
Colon-targeted L-glutamine capsule
Capsule formulation delivering L-glutamine to the colon to stimulate L-cell secretion of GLP-1 and other gut hormones; developed as a rapid-release colon-targeted capsule for metabolic modulation.
Services
Sponsor-side design and execution of early-stage clinical studies in type 1 and type 2 diabetes evaluating colonic delivery interventions and biomarker endpoints.
Development of sustained-release cores and application of colon-targeting coatings with sequential simulated GI testing to characterize release profiles for colonic delivery.
Regulatory planning for dual commercialization routes including 505(b)(2) NDA pathway and medical food classification to accelerate market entry.
Coordination of partnerships with manufacturing vendors, legal/IP advisors, and academic collaborators; management of grant-funded research programs.
Sponsor-side design and execution of early-stage clinical studies in type 1 and type 2 diabetes evaluating colonic delivery interventions and biomarker endpoints.
Development of sustained-release cores and application of colon-targeting coatings with sequential simulated GI testing to characterize release profiles for colonic delivery.
Regulatory planning for dual commercialization routes including 505(b)(2) NDA pathway and medical food classification to accelerate market entry.
Coordination of partnerships with manufacturing vendors, legal/IP advisors, and academic collaborators; management of grant-funded research programs.
Expertise Areas
- Clinical trial management in metabolic disease
- Colon-targeted drug delivery
- Sustained-release oral formulation development
- Preclinical metabolic pharmacology
Key Technologies
- Colon-targeted coating with dual pH and enzymatic activation
- Sustained-release tablet and capsule cores
- Simulated gastrointestinal dissolution testing (gastric → intestinal → colonic)
- Colonic delivery of short-chain fatty acids and amino acids (butyrate, L-glutamine)
News & Updates
In late 2022, BioKier completed a 12-week clinical study at three investigational sites, including Duke University and Pennington Biomedical Research Center.
BioKier completed a 4-week study of BKR-017 in type 2 diabetes subjects in late 2020, demonstrating effects on glucose regulation.
BioKier completed a 4-week clinical study in late 2020 with plans for future development.
BioKier was awarded a $3.0 million Phase IIb SBIR grant and a JDRF grant to study BKR-017 in type 1 diabetes patients.
BioKier filed four patent applications related to colon-targeted nutrient delivery, published in January 2023.
BioKier published an article in 'Functional Foods in Health and Disease' validating their approach to glucose management using colon-targeted nutrients.
In late 2022, BioKier completed a 12-week clinical study at three investigational sites, including Duke University and Pennington Biomedical Research Center.
BioKier completed a 4-week study of BKR-017 in type 2 diabetes subjects in late 2020, demonstrating effects on glucose regulation.
BioKier completed a 4-week clinical study in late 2020 with plans for future development.
BioKier was awarded a $3.0 million Phase IIb SBIR grant and a JDRF grant to study BKR-017 in type 1 diabetes patients.
BioKier filed four patent applications related to colon-targeted nutrient delivery, published in January 2023.
BioKier published an article in 'Functional Foods in Health and Disease' validating their approach to glucose management using colon-targeted nutrients.