KBP Biosciences Doses Final Patient in BLOCK CKD Phase 2b Study of KBP-5074
Aug 11, 2020

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 (GLOBE NEWSWIRE) -- 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.”

About KBP Biosciences

KBP Biosciences is a global, clinical stage biopharmaceutical company focused on the research and development of new chemical entities with known mechanisms of action targeting underserved patient populations. Headquartered in Princeton, NJ, KBP Biosciences has strong capabilities from Discovery and CMC through global clinical development and registration. The Company principally devotes its resources to three therapeutic areas: major organ protection, inflammation & autoimmune diseases, and anti-infectives.

The Company’s lead program, KBP-5074, a non-steroidal MRA discovered and developed by KBP’s scientists, is currently completing a global Phase 2b clinical trial for patients with uncontrolled hypertension in moderate and severe Chronic Kidney Disease patients. KBP is also developing KBP-7072, a Phase 2 ready third-generation aminomethylcycline for the treatment of multiple strains of drug-resistant infections with high activity against certain key pathogens.

KBP has built a proprietary R&D platform aimed at the discovery and development of global first-in-class compounds. The platform includes a compound library which is the basis of new compound discovery, a bacterium library aimed at multi-drug resistant bacteria, and an in vivo pharmacology platform for screening and testing new compounds. KBP Biosciences is actively seeking to identify additional promising therapeutic opportunities and further develop its product portfolio.