KBP Biosciences recently shared results for its BLOCK-CKD Phase IIb study and the positive trial results suggest KBP-5074 may become a viable competitor to the already established non-steroidal mineralocorticoid receptor antagonists (MRAs) for chronic kidney disease (CKD), according to GlobalData, a leading data and analytics company.

According to GlobalData’s Pharma Intelligence Center (PIC) drug database, KBP Biosciences has two leading products in development: KBP-5074 for uncontrolled hypertension in advanced CKD and KBP-7072 for infectious disease.

Kajal Jaddoo, Associate Pharma Analyst at GlobalData, comments: “A benefit of KBP-5074 over other anti-hypertensive MRAs drugs is that the drug has been proven to not increase the risk of severe hyperkalemia (HK), which is potassium levels above 7 milliequivalents per liter. This observation is significant because the Phase IIb trial included patients with stage 4 CKD, who are usually advised against the use of MRA drugs as it is linked to causing elevations in potassium levels in CKD patients.”

KBP-5074’s mechanism of action is a selective non-steroidal MRA that blocks the binding of aldosterone. Aldosterone stimulates principal cells through MRA receptors and signal cascade, which activates ENaC and renal outer medullary potassium channels, thereby stimulating the reabsorption of sodium and potassium excreted in the urine, respectively. As such, in CKD patients who noticeably suffer from fewer principal cells, a reduction in aldosterone levels can be detrimental to potassium excretion, leading to HK.

Jaddoo continues: “KBP’s Phase IIb study showed significant clinical improvement in systolic BP. The 0.5mg dose of KBP-5074 attained a mean 10.1mmHg reduction in systolic BP, in comparison to the placebo group (p=0.0029). In addition, KBP-5074 did not increase the risk of severe HK compared to placebo.”

A high proportion of stage 4 and 5 CKD patients have high blood pressure (BP). CKD patients with hypertension have accelerated progression compared to patients without the condition. The goal of anti-hypertensive treatment is to maintain BP to less than 140/90mmHg and 130/80mmHg for low-risk/high-risk and highest-risk groups.

Jaddoo adds: “According to GlobalData’s PIC Epidemiology database, the number of total prevalent cases of hypertension in the seven major markets (*7MM) is estimated to grow from 219 million cases in 2020 to 225 million by 2027. If approved, KBP-5074 will give CKD patients with uncontrolled hypertension an alternative treatment option. KBP is in the process of assessing its leading drug in the planned global Phase III study estimated to start December 2021.”

*7MM: US, France, Germany, Italy, Spain, UK, and Japan