● KBP-5074, a Non-Steroidal Mineralocorticoid Receptor Antagonist, Under Evaluation for the Treatment of Uncontrolled Hypertension in Advanced      Chronic Kidney Disease (CKD) Patients 

● Top Line Data Expected Fourth Quarter 2020

PRINCETON, N.J., May 20, 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 patient enrollment of BLOCK CKD (Blood Pressure in Chronic Kidney Disease), its Phase 2b study of its lead product candidate, KBP-5074, a highly-selective and potent non-steroidal mineralocorticoid receptor antagonist (MRA), in patients with moderate-to-severe chronic kidney disease (CKD) and uncontrolled hypertension. The Company expects to report top line data from BLOCK CKD in the fourth quarter of 2020.

BLOCK CKD is a randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy, safety, and pharmacokinetics of KBP-5074 in patients with moderate-to-severe CKD and uncontrolled hypertension. The study enrolled around 160 patients with an estimated Glomerular Filtration Rate (eGFR) of 15-44 mL/min/1.73m2 and systolic blood pressure (SBP) >140 mm Hg. Following a screening period of up to four weeks, participants received 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. At the conclusion of the dosing period, subjects will undergo a post-treatment observation period for four weeks. The primary endpoint of the study is change from baseline in SBP, with secondary endpoints evaluating diastolic blood pressure, ambulatory blood pressure change and change in urine albumin to creatinine ratio (UACR).

“Completion of enrollment marks an important milestone in the KBP-5074 development program,” said Thijs Spoor, Chief Executive Officer of KBP Biosciences. “We are highly encouraged by the data generated from previous studies of KBP-5074 and look forward to the data readout from BLOCK CKD later this year. This data will help inform the design of the planned Phase 3 clinical study of KBP-5074, for which we are targeting a 2021 initiation. I would like to thank our investigators, patients and their families for their support throughout the study. There is a critical unmet need for new therapies to treat these patients, and we believe that our drug has the potential to become a best-in-class treatment option.”

James McCabe, M.D., Vice President, Medical Director of Clinical Development and Medical Affairs of KBP Biosciences added, “As a practicing nephrologist I am excited about the potential of KBP-5074.  Currently approved therapies, including others in the MRA class, are characterized by severe and in some cases life-threatening side effects and contraindications, most notably the risk of hyperkalemia. KBP-5074 could provide a safe and efficacious treatment option to this large, underserved patient population.”

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