NEWTOWN SQUARE, Pa., Oct. 1, 2019 /PRNewswire/ -- 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/).
About Kibow® Biotech: Kibow® Biotech was founded on October 1st, 1997 at the University City Science Center incubator in Philadelphia, PA. The company specializes in research, development, and commercialization of patented and proprietary probiotic/prebiotic supplements. Kibow® Biotech's primary mission is to offer affordable, easily administered, and readily available healthcare supplements that support kidney and gut health. The company's flagship product, Renadyl™*, is currently marketed in the U.S.A., Canada, India, Mexico, and Malaysia. It will progressively be made available worldwide according to individual countries' governmental rules and regulatory authorities.
About Uremic Toxin Reduction Technology Platform – also known as "Enteric Dialysis®": Kibow® Biotech's novel "uremic toxin removal technology" addresses the diffusion of various uremic toxins into the bowel because of failing kidney function. The Company's patented and proprietary dietary supplements, Renadyl™ (for humans) and Azodyl® (a veterinary formulation licensed to Vetoquinol http://www.vetoquinolusa.com/ for cats and dogs with moderate to severe kidney failure) consists of a combination of three highly specific probiotic microbial strains along with prebiotics.
Kidney health supplement with a pharmaceutical-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 several factors. These include but are not limited to the possibility that Renadyl™ may not reduce levels of uremic toxins in each and every individual, due to differences that exist between individuals that cannot be controlled such as genetics and lifestyle factors, as well as environmental factors that would include proper storage of the product and conditions of transport of the product in the chain of commerce. 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 fulfill human drug product regulatory requirements 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 – CEO, Kibow Biotech, Inc.
(610) 353-5130 or Email: email@example.com
*These statements have not been evaluated by the US Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.
SOURCE Kibow Biotech Inc