PRINCETON, N.J., 30 November 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 the Hepatic Impairment study and Drug-Drug Interaction study of Ocedurenone (KBP-5074) was presented as posters at the ASN Kidney Week Conference November 4, 2022. The titles of the poster presentations are “Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist KBP-5074 in Individuals with Moderate Hepatic Impairment” and “Pharmacokinetics and Drug-Drug Interaction of KBP-5074 in Healthy Subjects”.
In the Hepatic Impairment study, small decreases of area under the plasma concentration-time curve (AUC) and Maximum plasma concentration (Cmax) upon systemic exposure to Ocedurenone (KBP-5074) in subjects with moderate hepatic impairment demonstrate low hepatic extraction and a dose adjustment does not appear to be warranted in patients with moderate hepatic impairment. Ocedurenone (KBP-5074) was safe and well tolerated in moderate hepatic impaired subjects.
In the Drug-Drug Interaction study, Ocedurenone (KBP-5074) was well tolerated when administered as a single 0.5-mg dose alone or in combination with Itraconazole or Rifampin. The study indicates that a strong Cytochrome P450 3A4 (CYP3A) inhibitor (Itraconazole) has a weak effect on Ocedurenone pharmacokinetic properties, with less than 2-fold change in Cmax and area under the curve time zero to time of last measurable concentration (AUClast); whereas a strong CYP3A inducer (Rifampin) has strong effect on pharmacokinetic properties of Ocedurenone, with about 5-fold decrease in AUC and terminal half-life(T1/2).
“The data indicated that there might not be need of dose adjustment in hepatic patients and co administration of CYP3A4 medication which is commonly used in the target population”, said James McCabe, MD, Deputy Chief Medical officer.
“Data from these studies add to the growing body of evidence supporting the use of Ocedurenone in clinical medicine” said Julia Yang MD, Chief Operations Officer of KBP, “and provide a compelling rationale for the use of Ocedurenone (KBP-5074) for the treatment of patients with CKD.”
About ASN Kidney Week
The world's premier nephrology meeting, Kidney Week provides participants exciting and challenging opportunities to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative discussions with leading experts in the field.
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.
For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/