PRINCETON, N.J., 1 December 2022 -- 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 results of a subgroup analysis of the Block-CKD Phase 2b clinical trial of Ocedurenone (KBP-5074) have been presented as a poster at the American Heart Association Scientific Sessions in Chicago November 5-7, 2022. The title of the poster presentation is “Effect of Ocedurenone (KBP-5074) in Patients with Uncontrolled Hypertension and Stage 3b/4 Chronic Kidney Disease - Subgroup Analysis of a Phase 2b Clinical Trial” with June Ye PhD as first author.
Block-CKD was a randomized, double-blind, placebo-controlled, multi-center, Phase 2b study to assess the efficacy, safety, and PK of KBP-5074 0.25 mg QD and KBP-5074 0.5 mg QD versus placebo in subjects with moderate to severe CKD and uncontrolled hypertension and demonstrated significant blood pressure lowering with minimum risk of hyperkalemia. The subgroup analysis was conducted to evaluate safety (eGFR change and serum potassium levels) and efficacy (SBP reduction) of Ocedurenone in patients across different CKD stages, and with or w/o diabetes. Similar small dose-dependent increases in serum potassium were observed in nearly all subpopulations. Consistent and clinically meaningful SBP reduction at Day 84 was observed in the subgroups analyzed. These conclusions are being confirmed in a larger ongoing Phase 3 trial (“Clarion-CKD”).
“The consistency of SBP reduction and safety data in more severe CKD patients with diabetes is very informative. The analysis supports the robustness of data supporting the use of Ocedurenone regardless of CKD stage, or diabetic status”, said Bertram Pitt, MD, University of Michigan “The data provides further justification for the use of Ocedurenone for the treatment of patients with CKD and uncontrolled hypertension”, said Fred Yang, Ph. D. Chief Development Officer of KBP
About AHA Scientific Sessions
The American Heart Association Scientific Sessions is the leading cardiovascular conference for basic, translational, clinical and population science in the United States. Attracting over 18,000 attendees per edition, these sessions include five days of comprehensive, unparalleled education through more than 5,000 presentations, with 1,000 invited faculty, 4,000 abstract presentations and a trade exhibition.
About KBP Biosciences
KBP Biosciences is a global, clinical-stage biotechnology company, headquartered in Princeton, NJ, focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet needs. KBP Biosciences’ pipeline includes 4 novel drug candidates, 2 currently in clinical development covering multiple indications. CLARION-CKD, the Phase 3 clinical trial of Ocedurenone (KBP-5074), with the first indication of advanced CKD and uncontrolled hypertension, is being conducted globally.
Ocedurenone (KBP-5074) is a non-steroidal MRA discovered and developed by KBP Biosciences. Ocedurenone (KBP-5074) selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors which can produce antihypertensive, renal and cardioprotective effects. At present, the Phase III clinical trial of the first indications of Ocedurenone (KBP-5074), advanced CKD and uncontrolled hypertension, is being conducted globally. Other indications of Ocedurenone are planned, including CV, CKD Progression, etc. Ocedurenone (KBP-5074) has been investigated in nine clinical studies including the BLOCK-CKD Phase 2b study. Ocedurenone(KBP-5074) is expected to provide a new treatment option addressing the unmet medical needs of patients with advanced CKD and uncontrolled hypertension.
About Advanced Chronic Kidney Disease (CKD) and Uncontrolled Hypertension
Current estimates of the prevalence of CKD indicate that there are 138 million adults with CKD in China alone. Available MRAs can provide additional blood pressure control in some of these patients, but usually will increase the risk of hyperkalemia. Many patients with stage 3b/4 CKD are at their maximum tolerated dose of anti-hypertensive medications and still have uncontrolled or resistant hypertension. Therefore, there is a huge unmet medical need in these patients.
E-poster link: Effect of Ocedurenone (KBP-5074) in Patients with Uncontrolled Hypertension and Stage 3b/4 Chronic Kidney Disease - Subgroup Analysis of a Phase 2b Clinical Trial: https://kbpbio.com/docs/2022%20AHA%20Poster%20-Effect%20of%20Ocedurenone%20in%20Patients%20with%20Uncontrolled%20Hypertension%20and%20Stage%203b4%20Chronic%20Kidney%20Disease%20-%20Subgroup%20Analys.pdf
For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/