● Single doses of 0.5 mg KBP-5074 were generally well tolerated in patients with severe CKD, with or without hemodialysis
● Overall drug exposure was significantly lower in hemodialyzed patients vs. non-hemodialyzed patients
● Drug concentration is not altered during or after hemodialysis
● Plasma aldosterone and serum potassium were generally comparable between the two patient groups Preprint published online on MedRxiv
PRINCETON, N.J., May 21, 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 the online publication of safety and pharmacokinetic (PK) results from a PK study of its lead product candidate, KBP-5074, a non-steroidal mineralocorticoid receptor antagonist (MRA), in patients with severe chronic kidney disease (CKD). A preprint was published in MedRxiv (https://doi.org/10.1101/2020.05.12.20053314), the preprint server for health sciences. KBP-5074, a highly selective and potent MRA, is in development to treat uncontrolled hypertension in patients with Stage 3B and 4 CKD.
This study was a multicenter, open-label study in patients with severe CKD with and without hemodialysis. The objective was to evaluate the safety and PK of single oral doses of 0.5 mg KBP-5074 in both groups and evaluate the effect of hemodialysis on PK profile. KBP-5074 was generally well tolerated in both hemodialysis (N=6) and non-hemodialysis (N=5) patients. Of the 11 patients in the study, there was only one case of transient hyperkalemia in a hemodialysis patient on Day 14, which resolved in two days and was not considered drug-related. The overall plasma exposure of KBP-5074 was lower in patients receiving hemodialysis. Hemodialysis did not directly alter the drug concentration. During the hemodialysis, the AUCs for inlet and outlet samples were similar, indicating minimal impact of hemodialysis on drug concentrations. Plasma aldosterone and serum potassium concentrations were generally comparable between the two groups.
“Patients suffering from both uncontrolled hypertension and advanced CKD are particularly challenging to treat,” said Thijs Spoor, Chief Executive Officer of KBP Biosciences. “The most commonly used anti-hypertensives are largely ineffective, and currently available MRAs are contraindicated because of the serious risk of hyperkalemia. We are encouraged by the safety and PK results seen in in this study of patients with severe CKD with and without hemodialysis. The results from this study, in combination with other studies we have conducted in both healthy normal and mild/moderate CKD patients, form the basis of dose selection for the BLOCK CKD trial, our Phase 2b study of KBP-5074 in patients with moderate-to-severe chronic kidney disease and uncontrolled hypertension, for which we recently completed enrollment and expect to report top line results by the end of 2020. In addition, the results of this study also provide dose selection guidance for any future studies in dialysis patients.”
Forward Looking Statements:
Certain statements in this press release are forward-looking. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on KBP’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. KBP does not undertake an obligation to update or revise any forward-looking statement. The information set forth herein speaks only as of the date hereof.