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Kibow Biotech Announces FDA Approval of IND to Initiate Phase II Clinical Trial of US-APR2020 to Treat Chronic Kidney Disease Stage IV

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April 13, 2021

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. 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.

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