Published: Apr 13, 2021
NEWTOWN SQUARE, Pa., April 13, 2021 /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/).
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