Company expands development plans for drugs which slow progression to dialysis

"The Trump administration has announced an ambitious plan to change treatment for kidney disease in the United States. President Trump signed an executive order on July 10th directing the Department of Health and Human Services [HHS] to develop policies addressing three goals: reducing the number of patients developing kidney failure, reducing how many Americans get dialysis treatment at dialysis centers, and making more kidneys available for transplant."

As a pioneer in the Enteric Dialysis® platform technology, Kibow® Biotech's mission has always been in conjunction with the standard care of therapy. The company's kidney health supplement product was developed to support normal kidney function which may help to slow the progression of kidney function in all stages of Chronic Kidney Disease (CKD) and potentially help a better outcome for dialysis patients worldwide.

Kibow® Biotech Inc is proud to announce that throughout its 22 years of operation, the focus on supporting and maintaining healthy kidney function with probiotics/prebiotics to potentially delay the progression to dialysis is based on its enteric toxin reduction platform technology termed "Enteric Dialysis®". Since 2005, Kibow® has been a pioneer and leader in the presently marketed kidney health supplement product, Renadyl™*.

Kibow® has been participating and exhibiting at various nephrology and medical professional annual meetings, like the American Society of Nephrology (ASN), National Kidney Foundation (NKF), American Association of Kidney Patients (AAKP), World Congress of Nephrology (WCN) and several other professional medical conferences since 2005.

Kibow®Biotech's participation in these events is intended to educate nephrology and all other medical professionals about the emerging importance and crucial role of probiotics/prebiotics, gut-kidney connection, dysbiosis, and modulation of the Gut Microbiome with its innovative "Enteric Dialysis®" platform technology.

Kibow® is committed to improving kidney health in patients with kidney problems, not only for Americans but in all countries worldwide. Although marketed and sold as a dietary supplement product, Renadyl™ is the first and only kidney health supplement developed and formulated based on clinical results that utilize Kibow® Biotech's patented and revolutionary "Enteric Dialysis®" technology.

Even before President Trump's announcement, Kibow® Biotech has been taking steps to reach and improve more patients' lives by diversifying Renadyl™ from health supplement to a novel live biotherapeutic drug product (micro-organisms) and obtaining approval as a new drug product. As an FDA-approved human drug, Renadyl™ will be able to be marketed based on specific health benefit claims which should lead to greater acceptance by healthcare professionals.

It will also pave the way for its medical reimbursement and could result in lower co-payment cost – both from private insurers and federal Medicare/Medicaid authorities. In addition to maintaining normal kidney function and slowing the progression of kidney disease, the goal would be to delay the need for expensive, physically and mentally taxing dialysis therapy.

As a LBP drug product, Renadyl™ may also be potentially useful in reducing the duration or frequency of dialysis with significantly improved quality of life and help save several billions of dollars spent not only in the USA but worldwide.

Kibow® has already initiated the Pre-Investigational New Drug (IND) application and subsequently will continue with the IND application process with US FDA's Center for Biological Evaluation Research (CBER) for its improved Renadyl™ Probiotics/Prebiotics formulation as a LBP drug product.

In order to gain drug approval, Kibow will be required to perform well-controlled, randomized clinical efficacy and safety testing. Kibow® has planned the "Kibow® Hope Study", a multisite, Randomized Controlled Trial (RCT) on CKD patients in stages III and IV.

The proposed Kibow® Hope RCT study will involve about 600 patients spread over 20 to 25 hospitals/clinics. The company intends to perform this multi-site RCT with the collaboration from highly accomplished clinical study investigators within the USA at their respective clinics/institutions/hospitals. Similar clinical trials will also be proposed and undertaken in several other countries.

Furthermore, it is known that 40% of CKD patients also suffer from gout due to higher levels of uric acid. Kibow® has developed a dietary supplement product which acts to maintain normal uric acid levels in blood, Animal studies have shown that the product reduces uric acid concentrations and also stabilizes blood pressure.

The company is in the process of performing open label Institutional Review Board (IRB) approved clinical studies monitoring similar endpoints in human subjects. Subsequently, Kibow® plans to explore the potential of another IND process with US FDA/CBER and seek FDA approval for gout/hyperuricemia applications. All Kibow® products have been developed based on selection of specific probiotic strains for CKD and Gout applications respectively.

Dr. Ranganathan, the founder and key R&D scientist of Kibow® states,

Use of various probiotic and prebiotic (fiber) products as dietary supplements are gaining greater public interest in children and adults for digestive, immune, and gut health. They are Generally Recognized As Safe (GRAS) by the US FDA. Renadyl™ as a kidney health supplement was introduced to US consumers in 2010 and subsequently exported to various oversea countries.

"No serious adverse events have been notified either to the company or US FDA after human use of Renadyl™ during the past nine years. This market experience provide support for the safety of Renadyl™ for kidney health applications.

Kibow® has been on the forefront of having developed and scientifically validated the concept of "ENTERIC DIALYSIS®" with its flagship product Renadyl™. Medical professionals and a large base of educated customers are always on the lookout and ready to adapt to a well-researched, Scientifically-based natural treatment."

Dr. Ranganathan's invited commentary titled Reality of "Enteric Dialysis®" with Probiotics and Prebiotics to Delay the Need of Conventional Dialysis published in the Journal of Nephrology & Therapeutics in 2018 can be accessed here.

Further updates will be made available during the upcoming American Society of Nephrology Kidney Week Meeting (November 5-10, 2019) in Washington DC where Kibow® has been participating as an exhibitor for the past 15 years