PRINCETON, N.J., 31 March 2023 -- KBP Biosciences PTE. Ltd. (“KBP Biosciences” or the “Company”), a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, today announced that dose administration for the first Chinese patient in CLARION-CKD (ClinicalTrials.gov Identifier: NCT04968184), a global Phase 3 clinical trial of Ocedurenone (KBP-5074), a novel non-steroidal, highly selective, mineralocorticoid receptor antagonist.
Ocedurenone is a non-steroidal MRA discovered and developed by KBP Biosciences. Ocedurenone selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors, resulting in more profound antihypertensive, renal, and cardioprotective effects. At present, the CLARION-CKD Phase III clinical trial targets the first indication of Ocedurenone, uncontrolled hypertension in patients with advanced CKD is underway. Other indications of Ocedurenone are planned, including CV risk reduction, CKD progression, heart failure, etc. Ocedurenone has already been investigated in nine clinical studies including the BLOCK-CKD Phase 2b study.
(Photo: KBP Biosciences Lab)
CLARION-CKD is a multicenter, double-blind, placebo-controlled, randomized Phase 3 study of Ocedurenone for uncontrolled hypertension in patients with advanced chronic kidney disease (CKD). CLARION-CKD follows the same inclusion criteria of the Phase 2b BLOCK-CKD study which achieved its primary endpoint with clinical and statistical significance: after 84 days, the placebo-subtracted treatment mean difference (SE) was −7.0 (3.37) mm Hg with KBP-5074 0.25 mg (P = 0.0399) and −10.2 (3.32) mm Hg with KBP-5074 0.5 mg (P = 0.0026). There were no reports of severe hyperkalemia or acute kidney injury with either dose of KBP-5074.
For the CLARION-CKD trial, a total of more than 600 patients will be randomized by more than 150 sites. The CLARION-CKD study has been initiated in the United States, Europe, Asia and the first patient dosed at the end of 2021. Recently, first patient has been dosed in China.
“Ocedurenone is expected to provide a new treatment option addressing the unmet medical needs of patients with advanced CKD and uncontrolled hypertension. BLOCK-CKD Phase 2b study assessed the efficacy, safety, and PK of ocedurenone for uncontrolled hypertension in patients with advanced CKD and demonstrated significant blood pressure lowering with without increasing the risk of hyperkalemia. Consistent and clinically meaningful SBP reduction was observed in BLOCK-CKD Phase 2b study. These conclusions are being confirmed in a larger ongoing Phase 3 trial (CLARION-CKD),” stated Julia Yang, MD, MBA, Chief Operating Officer of KBP Biosciences.
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 several novel drug candidates 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/