The US Foods and Drug Administration (FDA) approved Kibow Biotech, Inc., US-APR2020, to treat patients with chronic kidney disorders under the Investigational New Drug Application (IND).
The company has 23 years of experience in the development of probiotics and prebiotics (synbiotics) for use beyond the well-known benefits for gut health. Moreover, Kibow Biotech is a pioneer in probiotics and prebiotics that target gut microbiome modulation to treat dysbiosis-related health conditions.
This multisite trial’s primary efficacy endpoint is to halt the expected decrease in glomerular filtration rate (eGFR) by 40% from baseline. Modulating the gut microbiome with pro/prebiotics (synbiotics) to treat organ-specific health problems and unmet chronic medical conditions, including end-stage renal diseases, is a very ambitious goal.
The trial will investigate the unique combination of three carefully chosen probiotic strains of highly beneficial bacteria. This combination has been made based on decades of clinical testing and customer reviews of kidney well-being supplements.
Previous research demonstrated that this synbiotic improved the quality of life of people with kidney disorders. The underlying mechanism of action of the natural probiotics formulation US-APR2020 is metabolizing the toxic nitrogenous waste.
When probiotics expand and multiply, more nitrogen waste is consumed. Thus, the kidney functions are successfully maintained, and the other organs are protected from damage.
The researchers also believe that synbiotics for modulating the gut microbiota will be the future of kidney disorders treatment, improving outcomes and quality of life for these patients worldwide.
The enrollment for the phase II clinical trial is expected to begin in the third quarter of 2021, according to the company.