• • KBP-5074 is a novel non-steroidal MRA that addresses the unmet need for treatment of uncontrolled hypertension in patients with advanced chronic kidney disease without causing hyperkalemia.

• • Article published online 19 October 2021 in Expert Opinion on Investigational Drugs (EOID).

PRINCETON, N.J., November 30, 2021 — KBP Biosciences Co., 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 publication of an evaluation of KBP-5074 in advanced chronic kidney disease with uncontrolled hypertension by the peer-reviewed journal Expert Opinion on Investigational Drugs (EOID). Authored by Bertram Pitt, Frederic Jaisser, and George Bakris, this article provides an overview of the current state of resistant hypertension (RH) treatment in stage 3b/4 CKD as it relates to available steroidal mineralocorticoid receptor antagonists (MRAs) and the current limitations of this treatment. The authors then explore the emerging data on nonsteroidal MRAs, particularly the novel agent KBP-5074 and its applicability to treatment in this context. The results of the BLOCK-CKD study, previously published in the July 2021 print edition of Hypertension, are discussed.  

“The non-steroidal MRA Finerenone, which lowers systolic blood pressure (SBP) only by a few mm of Hg, has recently been approved by the FDA for preventing the progression of renal disease and cardiovascular events in patients with CKD and diabetes. The non-steroidal MRA KBP-5074, while still in development, has been shown to reduce SBP by around 10 mmHg placebo-subtracted and therefore should play an important role to patients with CKD both with and without diabetes who have treatment apparent resistant hypertension,” said Bertram Pitt MD, Professor Emeritus, Department of Medicine, University of Michigan School of Medicine.

 “While the steroidal MRAs, such as spironolactone are effective in lowering blood pressure (BP) in CKD patients, the risk of hyperkalemia is far too great to be used routinely in clinical practice. The results of the BLOCK-CKD study show the potential for KBP-5074 to be a best-in-class treatment option for patients with uncontrolled hypertension and advanced CKD,” said Zhenhua Huang, Ph.D, Chairman of KBP Biosciences. 

“Publication of this evaluation of KBP-5074 in a prestigious peer-reviewed journal highlights the potential of KBP-5074 in advancing care in this patient population. Following consultation with the FDA, we are excited to move into a global Phase 3 program this year,” added Fred Yang, Ph.D., Chief Development Officer of KBP Biosciences. 

“This publication highlights the importance and potential of KBP-5074 as a treatment option for patients with few, if any, options for treatment. I look forward to supporting the continuing development of KBP-5074 in a pivotal phase 3 trial,” said George Bakris, MD, Professor of Medicine and Director of the American Heart Association Comprehensive Hypertension Center at the University of Chicago Medicine.

About KBP Biosciences

KBP Biosciences is a global, clinical-stage biotech company focused on research and development of new chemical entities with known mechanisms of action targeting underserved patient populations. Headquartered in Princeton, NJ, KBP Biosciences has strong capabilities from Discovery and CMC through global clinical development and registration. The company principally devotes its resources to three therapeutic areas: major organ protection anti-infectives and respiratory. inflammation, and.

KBP has built a proprietary R&D platform aimed at the discovery and development of global first-in-class compounds. The platform includes a compound library as basis of new compound discovery, a library of multi-drug resistant bacteria, and an in vivo pharmacology platform for screening and testing new compounds. KBP Biosciences is actively seeking to identify additional promising therapeutic opportunities and further develop its product portfolio.

About KBP-5074

KBP-5074 is a non-steroidal MRA discovered and developed by KBP Biosciences Co., Ltd.  KBP-5074 selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors, suggesting that KBP-5074 should be effective in blocking the hypertensive and renal tissue damaging effects of aldosterone with reduced risk of pro-diabetic and adverse endocrine effects. KBP-5074 has been investigated in 9 clinical studies including the BLOCK-CKD phase 2b study. Phase 3 study preparations are underway in close consultation with FDA’s Division of Cardiology and Nephrology.

About Advanced CKD and Uncontrolled Hypertension

In the US alone, uncontrolled hypertension and stage 3b and 4 CKD afflicts more than 3 million patients in whom currently available MRAs are either contraindicated or must be used with extreme caution due to the risk of hyperkalemia. Treatments that lower blood pressure are available and include ACE-Is, ARBs, and diuretics among others.  Many patients with stage 3b/4 CKD are at their maximum tolerated dose and still have uncontrolled or resistant hypertension.  Available MRAs can provide additional blood pressure control in some of these patients, but usually not without the increased risk of hyperkalemia.

For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/.

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