KBP-5074 is a highly-selective non-steroidal mineralocorticoid receptor antagonist with potentially reduced hyperkalemia risk
Article published online; to be included in July 2020 print edition of Hypertension
PRINCETON, N.J., June 29, 2020 -- KBP Biosciences, a clinical stage biotechnology company dedicated to research, development and commercialization of innovative medicines for the global market, today announced the publication of the trial design for BLOCK CKD (Blood Pressure in Chronic Kidney Disease), the Company’s Phase 2b study of KBP-5074, a highly-selective and potent non-steroidal mineralocorticoid receptor antagonist (MRA) being studied as a treatment for uncontrolled hypertension in patients with advanced chronic kidney disease (CKD), in the peer-reviewed journal, Hypertension. The study design paper was published online, and will appear in the July 2020 print edition of the journal (DOI: 10.1161/HYPERTENSIONAHA.120.15199).
“We are honored to have this trial design manuscript accepted for publication in such a prestigious journal. The BLOCK CKD study is a potentially groundbreaking initiative in the treatment of uncontrolled hypertension in advanced CKD patients, a population in dire need of new therapeutic options,” said Fred Yang, Ph.D., co-author of the manuscript and Chief Development Officer of KBP Biosciences. “Publication of the study design in a prestigious peer-reviewed journal highlights the importance of the trial and the implications for advancing care in this patient population, assuming a positive outcome. We recently completed patient enrollment in BLOCK CKD and look forward to the read-out of the data from the trial, which we expect in the fourth quarter of 2020.”
BLOCK-CKD is a Phase 2b, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KBP-5074, on top of current therapy, in patients with Stage 3B/4 CKD (estimated glomerular filtration rate [eGFR] ≥15 and ≤44 mL/min/1.73 m2) and uncontrolled hypertension (trough cuff seated systolic blood pressure [SBP] ≥140 mmHg, despite treatment with maximally tolerated doses of two or more antihypertensive medicines with complementary mechanisms). Up to two-hundred-forty patients were planned to be randomized 1:1:1 to once-daily treatment with KBP-5074 0.25 mg, KBP-5074 0.5 mg, or placebo, stratified by eGFR (≥30 versus <30 mL/min/1.73 m2) and SBP (≥160 versus <160 mmHg). Approximately 30% of enrolled patients should have an eGFR of 15 to 29 mL/min/1.73 m2. The primary efficacy endpoint is the change in trough cuff seated SBP from baseline to Day 84 of each dose of KBP-5074 compared to placebo. Changes in the urinary albumin-creatinine ratio are being assessed along with changes in serum potassium/incidence of hyperkalemia, and changes in eGFR and serum creatinine. BLOCK-CKD will determine whether the addition of KBP-5074 will effectively lower blood pressure without an increased risk of hyperkalemia in patients who are not candidates for steroidal MRAs due to advanced CKD.