NEWTOWN SQUARE, Pa., Oct. 31, 2017 /PRNewswire/ -- Kibow Biotech is proud to announce its twentieth year of operations as a leader in the kidney health supplement marketplace. For the past 13 years, Kibow has been participating and exhibiting at the annual meeting of the American Society of Nephrology: Kidney Week event (https://www.asn-online.org/kidneyweek/) educating nephrology professionals on the crucial role of the gut-kidney connection, dysbiosis, and modulation of the Gut Microbiome with its innovative "Enteric Dialysis®" technology. Although marketed and sold in USA/Canada as a dietary supplement product, Renadyl™ is the first and only kidney health supplement formulated and developed with a pharmaceutical like validation, which utilizes revolutionary "Enteric Dialysis®" technology.
Originally conceptualized and founded as a drug company, Kibow Biotech looked to develop genetically engineered probiotics, which were able to use the toxins that build up due to reduced kidney function as nutrients/food. This concept of "Enteric Dialysis®" is based on the 1996 paper "Will the Bowel be the Kidney of the Future" written by world-renowned nephrologist Dr. Eli A. Friedman. Moving away from genetically engineered probiotics (due to technical and US FDA regulatory issues), the company discovered three specific naturally occurring strains of probiotics, and incorporated them into the kidney health supplement, Renadyl™. Renadyl™ has undergone a pharmaceutical-like validation process including: extensive R&D and Simulated Human Intestinal Microbial Ecosystem (SHIME) machine in vitro studies; 5/6th nephrectomized animal studies in rats and pigs; live animal studies in cats, dogs and retired zoo animals with moderate to severe kidney failure (lions, tigers, cougars and sea lions); safety dose-escalation clinical trials in humans; and efficacy clinical trials in CKD and dialysis patient populations in USA, Canada, Nigeria and Argentina.
Added proof of "Enteric Dialysis®" has come in the form of three consecutive customer surveys (2013, 2015, and 2017). The three surveys showed the overwhelmingly positive impact "Enteric Dialysis®" via Renadyl™ had on the user's quality of life. The most recent survey, in addition to quality of life, demonstrated a stabilization of kidney function measured by Glomerular Filtration Rate (GFR). GFR is the primary metric for assessing kidney function, and is used to classify stages of CKD. These preliminary results bode well for meeting the primary endpoints in the upcoming placebo controlled, large-scale clinical trial titled "Hope Study."
The Hope Study protocol will be designed as a multi-site Health Economics and Outcomes Research (HEOR) clinical trial (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4031700/) conducted in the United States in CKD III and IV patient populations. Metrics such as kidney function (GFR), quality of life, and other standard metabolic parameters will be measured and analyzed to further document Renadyl' s clinical impact. In addition, Hope Study will incorporate health economics measures, in order to assess the economic impact of Renadyl™. The US federal government spends roughly $35 billion on dialysis care, plus an additional $25 billion in pre-dialysis care each year. Slowing the progression of CKD with an effective and inexpensive alternative can help reduce the healthcare cost of dialysis and pre-dialysis tremendously. The company is also planning to conduct similar HEOR double-blind Randomized Control Trials (RCTs) in several other countries, specifically: Canada, Mexico, Japan, China, India and Europe.
With 20 years of R&D and clinical trial expertise, Kibow Biotech's vision is to provide an inexpensive, convenient and efficacious kidney health supplement that could be useful for over 300 million people suffering from CKD worldwide. Preliminary data looks promising, showing not only an arresting of the decline of GFR, but stabilization and also in majority of cases increased GFR in all stages of kidney disease with individuals standard care of therapy. Hence, multisite RCT clinical trials are scheduled in USA to be initiated in the coming year. Such clinical trials and validation of a pharmaceutical like primary end point (https://www.kidney.org/news/new-endpoints-ckd-clinical-trials-gaining-traction-regulators) could allow for significant reduction in the cost of treating CKD, which is a non-communicable chronic disease. Kibow Biotech has also developed a similar technology Probiotics/prebiotics all natural, safe, US FDA's - Generally Recognized as Safe (GRAS) product formulation targeted towards Gout/Hyperuricemia applications.
Forward looking statements: This press release contains forward-looking statements that reflect management's current views of future events, including the status of development of the dietary supplement formulation, Renadyl™, for kidney health in the USA and the possibility of its approval as a drug in some other countries according to respective governmental authorities.
About Uremic Toxin Reduction Technology – also known as "Enteric Dialysis®": Kibow's novel "uremic toxin removal technology" addresses the diffusion of various uremic toxins into the bowel as a consequence of failing kidney function. The Company's patented and proprietary dietary supplements, Renadyl™ (for humans) and Azodyl® for cats and dogs with moderate to severe kidney failure (a veterinary formulation licensed to Vetoquinol http://www.vetoquinolusa.com/) consists of a combination of three specific probiotic microbial strains and chosen prebiotics.
Kidney health supplement with a pharma-like validation: Kibow Biotech is not a pharmaceutical company. Kibow products are not drugs and may not be considered as a treatment or a therapy. The dietary supplement formulation of Renadyl™ is not meant to cure, prevent or mitigate any disease. Actual results may differ significantly from the above forward-looking statements due to a number of factors, including but not limited to the possibility that Renadyl™ may not show evidence of clinical activity in each and every individual, due to various genetic factors or environmental factors including proper storage, and transportation conditions. Other factors that could cause or contribute to differences in actual results include, but are not limited to: whether or not the Company or any of its collaborators will be able to develop drug pathway using the technologies of the Company; whether the cash resources of the Company will be sufficient to fund operations as planned; reliance on key employees, especially senior management; the uncertainty of the Company's future access to capital; the risk that the Company may not secure or maintain relationships with collaborators; and the Company's dependence on intellectual property. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.
Investor & Media Contact:
Terrence O. Tormey
(610) 353-5130 or Email: [email protected]
SOURCE Kibow Biotech, Inc.