Kibow® Biotech Inc, a pioneering probiotic company in gut modulation with its novel "Enteric Dialysis®" technology platform, is celebrating its 22-year anniversary on October 1st, 2019. This innovative company began with the idea that modulating the gut microbiome (when the word microbiome was non-existent) could help people with Chronic Kidney Disease (CKD), a group with limited treatment options.
For 22 years, Kibow® has focused on researching and developing kidney health dietary supplement products based on the concept of offsetting failing KIdney function by utilizing the microbiome of the BOWel (hence the name KIBOW) to remove toxins. This is based on the properties of highly strain-specific and selective probiotics and prebiotics for several gut modulating applications. Kibow® is well recognized for its flagship product Renadyl™ (a pre/probiotic for kidney health), Kibow Fortis® (a multi-fiber for wellness), Kibow Flora™ (a probiotic for immune health) for humans, and Azodyl™, a veterinary kidney failure product designed especially for cats and dogs (exclusively licensed to Vetoquinol USA since July 2006). The company is also exploring the development of new organ function-targeted dietary supplement products and thus expanding its portfolio of products in the coming year.
The currently marketed Kibow® supplements for humans and pets are categorized by the US FDA as dietary supplements. Although the products have been developed with Pharma-like validation (https://kibowbiotech.com/rd/) (https://kibowbiotech.com/journal-publications/) over two decades, the potential use of these products is limited by US FDA/FTC regulations, as no healthcare or disease treatment claims can be made. Also, these products, as dietary supplements, are not qualified to garner medical reimbursement. In view of these limitations and a desire to reach and help more Chronic Kidney Patients, Kibow® has developed a newer and more advanced Live Biotherapeutic (LBP) formulation to be scientifically advanced as a US FDA approved and clinically validated pharmaceutical product.
As probiotics are live microbes, this new product will fall under the Live Biotherapeutic Product (LBP) drugs under the Center for Biological Evaluation Research (CBER) and the US FDA regulations. This will be the first LBP drug for CKD patients in the United States and would qualify for medical reimbursement. The company is initiating the IND process and is planning the required clinical trials. Upon successful completion of the proposed randomized, controlled clinical studies in CKD III/IV patients and submission of the data to FDA for review and approval, Kibow® will gear up to launch its LBP drug product in 2023 in the United States as well as other countries. This will help ensure that many more patients will be able to access and afford this novel treatment option.
Kibow® is also planning additional clinical trials in patients undergoing dialysis to explore improved outcomes and the potential for reduction in the duration and/or frequency of dialysis. This clinical trial is also expected to be completed before 2023. Kibow® is looking forward to this next milestone that could immensely benefit dialysis patients and considerably reduce Medicare expenses for the US Health Care System by several billions of dollars. Kibow® Biotech's launch of its wholly-owned pharmaceutical division and its action to move forward to seek LBP drug status is in line with the mission of recently created HHS/ASN KidneyX (https://www.kidneyx.org/) program as well as the executive order signed by the president towards advancing Kidney health (https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/).