PRINCETON, N.J., 31 October 2023 -- KBP Biosciences PTE, Ltd. (“KBP Biosciences”), a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, today announced completion of its target enrollment of the Phase 3 CLARION-CKD study of ocedurenone, a non-steroidal, high affinity, mineralocorticoid receptor antagonist.
“Completion of enrollment to this study excites the medical community that ocedurenone could potentially address the unmet needs of millions of patients worldwide who suffer from uncontrolled hypertension and have advanced CKD,” stated George Bakris MD, Professor of Medicine and Director of the American Heart Association Comprehensive Hypertension Center at the University of Chicago Medicine. “The completion of enrollment to the CLARION-CKD Phase 3 study is a significant event in the development of ocedurenone and reflects the ongoing commitment of KBP Biosciences to address the global unmet medical needs of the cardiorenal community,” stated Fred Yang PhD, Chief Development Officer of KBP Biosciences and the chief architect of the development program of ocedureneone. “Achievement of this event reflects the operational excellence of KBP’s clinical department and its collaborators in conducting this difficult-to-enroll global study. It firmly showcases KBP Biosciences as a world-class biotechnology research & development organization dedicated to providing innovative therapies for unmet medical needs,” stated Julia Yang, MD, MBA, Chief Operating Officer of KBP Biosciences.
About Clarion-CKD Phase 3 Study
CLARION-CKD is a multicenter, double-blind, placebo-controlled, randomised phase 3 study of ocedurenone for uncontrolled hypertension in patients with advanced chronic kidney disease (CKD). CLARION-CKD follows the same inclusion criteria as the phase 2b BLOCK-CKD study which achieved its primary endpoint with clinical and statistical significance. For the CLARION-CKD trial, a total of more than 600 patients will be randomised by more than 150 sites. The CLARION-CKD study has been initiated in the United States, Europe, Asia and the first patient was dosed at the end of 2021.
About KBP Biosciences
KBP Biosciences is a global, clinical-stage biotechnology company, headquartered in Singapore, focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet medical needs. KBP Biosciences’ pipeline includes four novel drug candidates, two currently in clinical development covering multiple indications. CLARION-CKD, the global Phase 3 clinical trial of ocedurenone (KBP-5074), is being conducted in patients with advanced CKD and uncontrolled hypertension. For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com.
About Ocedurenone
Ocedurenone is a third-generation, non-steroidal, mineralocorticoid receptor antagonist (MRA) with a unique pharmacokinetic (PK) profile characterized by a long half-life and high mineralocorticoid receptor (MR) affinity. Certain MRAs have shown benefits in people with hypertension or heart failure, as well as cardiorenal benefits in patients with chronic kidney disease (CKD) and type 2 diabetes [1]. Patients with cardiovascular disease, CKD, or diabetes are at greater risk for hyperkalemia (elevated potassium in the blood), an electrolyte abnormality that can cause muscle weakness, paralysis, cardiac arrhythmias, and sudden cardiac death. Renin-angiotensin-aldosterone system (RAAS) inhibitors, a group of drugs that includes MRAs, are known to further increase the risk of hyperkalemia. Based on clinical studies conducted to date, ocedurenone has the potential to have favorable efficacy (blood pressure reductions) and tolerability (lower risk of hyperkalemia) [2]. On 16 October 2023, it was announced that Novo Nordisk has agreed to acquire ocedurenone from KBP Biosciences. The closing of that acquisition is subject to receipt of applicable regulatory approvals and other customary conditions and is expected to happen before the end of 2023.
For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com.
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Kintscher U, et al. Br J Pharmacol. 2022 Jul;179(13):3220-3234. Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease - PubMed (nih.gov)
Bakris G, et al. Hypertension. 2021 Jul;78(1):74-81. Effect of KBP-5074 on Blood Pressure in Advanced Chronic Kidney Disease: Results of the BLOCK-CKD Study - PubMed (nih.gov)