KBP-5074 Being Evaluated for the Treatment of Uncontrolled Hypertension in Advanced Chronic Kidney Disease (CKD) Patients

Top-Line Data on Track for Fourth Quarter of 2020

PRINCETON, N.J., Aug. 05, 2020 -- KBP Biosciences, a clinical-stage biotechnology company dedicated to research, development and commercialization of innovative medicines for the global market, today announced that it has completed treatment of the final subject in BLOCK CKD (Blood Pressure in Chronic Kidney Disease), its Phase 2b study of lead product candidate, KBP-5074, a highly-selective and potent non-steroidal mineralocorticoid receptor antagonist (MRA), in patients with advanced (stage 3b/4) chronic kidney disease (CKD) and uncontrolled hypertension. The Company expects to announce top-line data from BLOCK CKD in the fourth quarter of 2020.

“As we further advance the KBP-5074 program, enthusiasm from the nephrology community continues to grow. Completion of patient treatment in BLOCK CKD marks the latest milestone in the development of this novel, potentially best-in-class compound,” said Thijs Spoor, Chief Executive Officer of KBP Biosciences. “We are eagerly anticipating the data readout from the study in the coming months and look forward to the planned initiation of our Phase 3 study, which we expect to occur in 2021. We maintain our strong belief that KBP-5074 represents a potential breakthrough in the treatment of advanced CKD patients with uncontrolled hypertension.”

BLOCK CKD is a randomized, double-blind, placebo-controlled, global study to assess the efficacy, safety, and pharmacokinetics of KBP-5074 in patients with advanced (stage 3b/4) CKD and uncontrolled hypertension. The study enrolled 162 patients with an estimated Glomerular Filtration Rate (eGFR) of 15-44 mL/min/1.73m2 and systolic blood pressure >=140 mm Hg. Following a screening period of up to four weeks, participants received a placebo for a two week run-in period. Upon completion of the placebo run-in, subjects were randomized to receive either placebo, 0.25mg, or 0.5mg of KBP-5074 once daily for 12 weeks, followed by a four-week post-treatment observation period. The primary endpoint of the study is the change from baseline in systolic blood pressure, with secondary endpoints evaluating diastolic blood pressure, ambulatory blood pressure change, and the change in the urine albumin-to-creatinine ratio.

James McCabe, M.D., Vice President, Medical Director of Clinical Development and Medical Affairs of KBP Biosciences, added, “The patients in the study suffered from uncontrolled hypertension despite most of them being on three or more antihypertensive drugs. In previously completed studies, KBP-5074 has demonstrated an ability to effectively lower blood pressure, even in patients already on multiple antihypertensives, without the risk of hyperkalemia usually associated with steroidal MRAs. We are hopeful that a similarly-significant patient benefit will be seen in this study, which would be an important step forward in our effort to bring KBP-5074 to patients in need.”

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