24-Year-Old Kibow Biotech/Pharmaceuticals Company of Pennsylvania, USA Supports World Kidney Day 2022 on its Mission “Kidney Health for All.”
NEWTOWN SQUARE, Pa., March 10, 2022 /PRNewswire/ — Kibow Biotech is pleased to announce that it is joining and celebrating World Kidney Day (WKD) on March 10, 2022. Its theme is Kidney Health for All, with an effective social media campaign and financial support towards its activities. This year’s campaign aims to bridge the high knowledge gap among stakeholders to improve better kidney disease care at all levels of patients’ quality of life. In addition, Kibow Biotech will continue to support the various awareness campaigns educational and preventive health programs among major stakeholders in the community, health workers, and public health policymakers to reduce the enormous challenges with over one hundred billion dollars in kidney disease management. Kidney disease is now taking center stage on awareness and a burden to healthcare expenditure (News: CKD moves to center stage with launch of Kidney Care Choices model).
Chronic kidney disease (CKD) affects about 10 % of the adult population worldwide and 15% of the US population. It is associated with high healthcare costs and mortality. Furthermore, CKD is a global public health threat and is projected to be the 5th leading cause of death by 2040. Hence raising public awareness and bridging the knowledge gap is a weapon we all need to fight against kidney diseases and increased mortality.
In this regard, Kibow Biotech’s team and partners have, for over 24 years, been involved in R&D to provide solutions and support people worldwide struggling with kidney failure. Kibow has been at the forefront of helping CKD patients and families navigate their kidney health through educational materials and continuous research efforts in developing new dietary supplement formulations that provide additional health benefits and improve the quality of life for consumers. Kibow focus on kidney health has been to delay dialysis in CKD stage IV patients with the patented proprietary probiotic dietary supplement formulation Renadyl™ marketed since April 2010 (www.renadyl.com). Kibow’s platform technology is known as “Enteric/Intestinal Dialysis,” which metabolizes various uremic toxins that diffuse from the circulating blood into the bowel (Platform Technology Video).
In furtherance of Kibow’s scientific R&D and drug development programs, a separate pharmaceutical division was launched in 2019 to transition the kidney health probiotic supplements to a drug grade Live Biotherapeutic Product (LBP) category. The Company obtained an FDA-approved IND for US-APR2020 for Phase 2b Clinical Trial to evaluate safety and efficacy in 630 subjects with CKD stage IV. This first large-scale Phase 2b randomized, double-blind controlled clinical trial has been actively recruiting subjects in 20 USA sites since October 2021 and hopes to complete the study before the end of this year (NCT04913272). The Company is also exploring its use and clinical benefits of improved Pro/Prebiotics formulations to Pediatric CKD subjects whose current therapeutic options are limited.
Additionally, the Company’s clinical development program is also in the process of submitting an IND application with the US FDA and obtaining IND approval to evaluate the CKD stage 4 formulation, US-APR 2020, with an additional specific probiotic strain selected for its ability to reduce catheter and hospital infection in patients undergoing routine hemodialysis for three times a week and four hours per session or less. This study is poised to evaluate the potential for reducing the duration and/or frequency of dialysis with improved quality of life and better outcomes.
Since 1997, Kibow Biotech, Inc has continually researched, developed, and commercialized probiotic dietary supplements adhering to US FDA and FTC regulations. The Company has carried out this primary mission by offering readily available, accessible, and affordable formulations to support kidney health and other clinical applications by marketing their products in the US and various other countries worldwide, depending on the individual country’s regulatory authority requirements. Furthermore, the Company’s efforts to transition to LBP classification will be able to make a therapeutic claim and thus qualify for medical reimbursement – both from Medicare and private medical insurance companies. Therefore, our Company’s quarter-century of efforts is to validate, scientifically support, and align our philosophy with the recently launched Kidney Care Choices model by the Centers for Medicare and Medicaid Innovation (CMMI) for CKD stages 4 and 5. The goals of the clinical development programs of Kibow Biotech and Kibow Pharmaceutical are to create awareness around kidney health, offer treatment choices and improve the quality of life for all stages of CKD patients worldwide.
For further information, contact:
Dr. Emmanuel Anteyi, MD, MBA, MSHS, FRCP (Lon) Medical/Clinical Director
Phone: (610) 353-5130
About Kibow Biotech, Inc. Founded October 1, 1997, in Philadelphia, Kibow Biotech specializes in research, development, and commercialization of probiotic dietary supplements adhering to US FDA and FTC regulations. The Company’s primary mission is to offer affordable, readily available, and easily administered nutritional supplements to support kidney health and other healthcare applications. Adhering to individual countries’ governmental rules and regulatory authorities, the Company’s flagship product, Renadyl™, is marketed in the US and Canada, and several other countries as a kidney dietary supplement product. The Company’s extensive scientific (R&D) and clinical data, including three pilot/observational human clinical trials, have been published in peer-reviewed scientific /medical journals (https://www.kibowbiotech.com/rd/).
About Kibow Pharmaceuticals, LLC. Kibow Pharmaceuticals, LLC., (a Delaware Limited Liability Company), is a wholly-owned subsidiary of Kibow Biotech, Inc. The pharmaceutical division was established in 2019 primarily for clinical development to evaluate the safety and efficacy of live biotherapeutic pharmaceutical products (LBP).
Forward-looking statements; This press release contains forward-looking statements that reflect management’s current views of future events. These statements include the status of development and transition of the currently marketed kidney health dietary supplement for its greater recognition, acceptance, and business potential as a “Live Bio-therapeutic Product (LPB)” benefits in the USA and other countries. For the present, Kibow® products are not drugs and may not be
considered a treatment or a therapy. The dietary supplement formulation of Renadyl™ is not meant to cure, prevent, or mitigate any disease. Due to several factors, the proposed clinical data results as LBP results may differ significantly from the above forward-looking statements. These include, but are not limited to, the possibility that Renadyl™ may not reduce levels of uremic toxins in 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 the law requires.
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SOURCE Kibow Biotech, Inc.