NEWTOWN SQUARE, Pa., Oct. 1, 2021 /PRNewswire/ — Kibow Biotech Inc., a clinical-stage biotechnology company, is celebrating its 24th Anniversary. Kibow Biotech was founded on October 1, 1997, in Philadelphia and specialized in researching, developing, and commercializing probiotic dietary supplements, adhering to US FDA and FTC regulations. The Company’s principal mission is to offer affordable, accessible, and orally administered nutritional and health supplements primarily for failing kidney function. Kibow Biotech is a pioneer in modulating the gut microbiome, with its patented and proprietary formulation for uremic toxin removal in patients with chronic kidney disease. Kibow platform technology is known as "Enteric/Intestinal Dialysis", which metabolizes various uremic toxins that diffuse from the circulating blood into the bowel. In addition, the precisely chosen probiotic microbial strains and specifically selected prebiotics (functional fibers) product formulation decrease several putrefactions generated by cardiovascular toxins; this will resolve the dysbiotic metabolic pathways to improved outcomes and result in better Quality of Life (QOL) in all stages of CKD.
The kidney health supplement Renadyl™ for humans has been marketed worldwide since 2010. This product has also been exclusively licensed to Centaur Pharmaceuticals, Mumbai, India, for the domestic, SAARC, and several neighboring countries, effective since 2018. For the past sixteen years, the veterinary product – Azodyl™ for cats and dogs with moderate to severe kidney failure was licensed to Vetoquinol, SA (France) and established as the #1 product for vet kidney health worldwide. Kibow’s product portfolio also includes patented and proprietary supplements marketed via its online store and on Amazon. These are multifunctional fibers – Kibow Fortis®, Kibow Flora™, Kibow® Cardio Support, and the recently launched immune-enhancing Kibow Biommunity™(www.kibowbiotech.com).
All Kibow supplements are developed with a pharma-like validation. We are pleased to notify you that no reports of adverse events of any kind have been reported to the Company or US FDA by consumers in the past ten years. Despite the documented evidence of safety and clinical benefits to consumers, access to Kibow products in the USA is limited by US FDA /FTC regulations, as no healthcare or disease treatment claims can be made. Been classified as dietary products, they are not qualified for health provider prescription and any medical reimbursement.
Because of these limitations and the desire to reach and help more chronic kidney patients, Kibow Pharmaceutical LLC., (www.kibowpharma.com) was launched in 2019 specifically for clinical development of newer and advanced live biotherapeutic product formulation through FDA/CBER approval pathway leading to validated pharmaceutical like prescription drugs. Hence, the Company has opted to perform the IND, US FDA-approved, randomized controlled Phase 2(b) clinical trial to evaluate the safety and efficacy of live biotherapeutic product (US- APR 2020) in 630 subjects with CKD-IV (https://clinicaltrials.gov/ct2/show/NCT04913272?term=nct04913272&draw=2&rank=1) has begun and will be carried out in about 20 US clinical sites. The primary endpoints are adverse events in less than 10% and mean reduction in the decline of eGFR by 40% as per NKF/FDA guidelines in subjects treated with investigative product compared to placebo(https://pubmed.ncbi.nlm.nih.gov/25441437/).
Seven clinical trial sites have started screening and enrolling subjects in September 2021, and the remaining 13 sites are scheduled to complete recruitment between October and December 2021. The goal is to validate the delay of dialysis on CKD-IV patients in conjunction with their individual standard of care with the addition of the US-APR2020 investigative product.
Kibow Pharmaceutical has also developed the protocol for exploratory safety and efficacy of another live biotherapeutic product to explore the potential to improve dialysis adequacy, quality of life and reduce dialysis duration or frequency. This clinical trial is expected to kick start in April 2022. In addition, the Company is also exploring a crucial clinical trial on pediatric CKD patients. We are in communication and discussion with three expert Pediatric Nephrologists at their respective medical institutions in Washington DC, North Carolina, and Texas.
The mission of Kibow Pharmaceutical aligns with the goals of the HHS/ASN collaborative Kidney X (https://www.hhs.gov/cto/initiatives/kidneyx/index.html ) program; The White House executive order of the US President towards advancing and improving innovations in Kidney Health in the USA (https://trumpwhitehouse.archives.gov/presidential-actions/executive-order-advancing-american-kidney-health/).
As a corporate member of the American Association of Kidney Patients (AAKP), Kibow pioneering and sustained efforts in gut microbiome modulation in addressing the needs of chronic kidney disease patients support the 2019 Washington DC declaration of "Decade of the Kidney™" (https://aakp.org/center-for-patient-engagement-and-advocacy/decade-of-the-kidney/).
Diabetes is the leading cause of kidney failure, accounting for 44% percent of new cases. High blood pressure is the second leading cause of kidney failure in the US after diabetes. Approximately 1 in 5 adults (20%) in the US with high blood pressure may have CKD. Dr. Natarajan Ranganathan, the founder, chief R&D scientist with roots from India, commented, "Kibow is looking forward to these future clinical (LBP) development milestones that could reduce the burden and immensely benefit all global chronic kidney disease patients." Besides, the products would considerably reduce Medicare and Medicaid spending by the US health care system exceeding $100 billion/year on all stages of CKD, including over 600,000 patients on dialysis. The "Enteric/Intestinal Dialysis" of Kibow is a novel uremic toxin removal technology that aligns with AAKP goals to accelerate patient choices, targeted therapies, and greater access to innovations in the management of kidney disease worldwide.
The Company is seeking collaboration/ investment of $25M in Series A growth capital for its pharmaceutical division.
For further information, contact:
Dr. Emmanuel Anteyi, MD, MBA, MSHS, FRCP (Lon)
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 (http://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 as 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 required by law.
SOURCE Kibow Biotech Inc