Expect to Enroll 630 Patients in this one Year Study to Begin in Q3 2021
Newtown Square, PA /PRNewswire/ - Kibow Biotech, Inc., a clinical-stage biotechnology company pioneering the discovery and development of probiotics and prebiotics (synbiotics) for the treatment of kidney diseases beyond gut health, today announced that the U.S. Food and Drug Administration (FDA) had approved the Company's Investigational New Drug Application (IND) for US-APR2020 to treat patients with Chronic Kidney Disease (CKD) stage IV. The primary efficacy endpoint for the multisite trial is to arrest the decline of estimated Glomerular Filtration Rate (eGFR) by 40% from baseline as per the American Society of Nephrology (ASN), National Kidney Foundation (NKF), and US FDA (https://pubmed.ncbi.nlm.nih.gov/25441437/).
"The FDA's approval of our IND is a significant milestone in transitioning Kibow Biotech from a 23-year-old kidney health supplement to a live biotherapeutic product under the Center for Biologics Evaluation and Research (CBER) and US FDA regulations," Natarajan Ranganathan, Ph.D., Chairman and Founder, Kibow Biotech, said. "We look forward to embarking on our next chapter as a phase II/III clinical-stage biopharmaceutical company, harnessing the novel "Intestinal Dialysis™" platform technology to modulate the gut microbiome with our natural proprietary pro/prebiotics (synbiotics) to address organ-specific health conditions and target unmet medical diseases. As is becoming evident, the dysbiosis of the gut microbiome is the cause of various diseases. Kibow Biotech has been a pioneer in using Pro/Prebiotics targeting gut microbiome modulation to alleviate dysbiosis in CKD/End-Stage Renal Disease (ESRD) patients.
This unique and novel study is designed as a double-blind, randomized, placebo-controlled, phase II clinical trial to evaluate the effect of US-APR2020 in patients with CKD stage IV for six months and followed to continue as an open-label trial on all enrolled patients for another six months, with total completion of one year. For a summary of this study information, please see the following PDF: https://kibowpharma.com/pdf/Protocol_Summary__CKD_4_630_patients.pdf
"With three specifically chosen probiotic strains of highly beneficial targeted bacteria, we selected this unique blend based on our decades of clinically tested and consumers' very positive feedback on the kidney health supplement. Our science has demonstrated the ability of this unique blend to improve the quality of life in people with kidney diseases," added Dr. Ranganathan. "We believe the future of kidney care will be the use of synbiotics in modulating the gut microbiome to improve better outcomes and quality of life for CKD/ESRD patients worldwide."
Clinical site initiation activities are underway for the phase II clinical trial of US-APR2020. The Company anticipates the enrollment to begin in the third quarter of 2021. In this regard, Kibow recently has launched a separate wholly-owned pharmaceutical subsidiary division, called Kibow Pharmaceuticals, LLC. (http://kibowpharma.com/). We acknowledge the guidance and services of Mukesh Kumar, Ph.D., RAC, our strategic regulatory consultant, and his team from Brij Strategic Consultations, LLC, MD. (www.FDAmap.com).
US-APR2020 is a natural probiotics formulation that metabolizes nitrogenous waste, which generally diffuses from the circulating bloodstream into the bowel. When these waste products accumulate in high concentrations in the blood, they become highly toxic and can cause severe damage to many organ systems if they are not properly excreted. US-APR2020 utilizes nitrogenous wastes as nutrients. As probiotics grow and multiply, they consume more nitrogenous waste and effectively maintain healthy kidney function.
About Kidney Disease
Globally, over 800 million patients are affected with CKD, increasing by about 7% per year. In the United States, 37 million adults are estimated to have chronic kidney disease, and approximately 90 percent do not know they have it. 1 in 3 adults in the U.S. is at risk for chronic kidney disease. Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity, and family history. Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, or Native Hawaiian or Other Pacific Islander are at increased risk for developing the disease. Black or African American people are almost four times more likely than Whites to have kidney failure. Hispanic or Latino people are 1.3 times more likely than non-Hispanic or non-Latino people to have kidney failure (Source: NKF).
About Kibow Biotech, Inc. and Kibow Pharmaceuticals, LLC.:
Founded October 1, 1997, in Philadelphia, Kibow Biotech specializes in research, development, and commercialization 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 different pilot/observational human clinical trials data, have been published in peer-reviewed scientific /medical journals (http://www.kibowbiotech.com/rd/).
This press release contains forward-looking statements that reflect management's current views of future events, including 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. Actual proposed clinical data results as LBP 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.