KBP Biosciences Meets Primary Endpoint for BLOCK-CKD Phase 2b Study of KBP-5074 for the Treatment of Uncontrolled Hypertension in Advanced Chronic Kidney Disease Patients

KBP-5074 Achieves 10.1 mmHg reduction in systolic blood pressure (SBP) at 0.5mg dose compared to placebo

Positive diastolic blood pressure (DBP) and Urine Albumin-to-Creatinine Ratio (UACR) Trends

No drug-related treatment-emergent serious adverse events

PRINCETON, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) — KBP Biosciences Holdings Limited (KBP Biosciences), a global, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet needs, today announced positive top-line results from its Phase 2b clinical trial (BLOCK-CKD) of its lead product candidate, KBP-5074. KBP-5074 is a potentially best-in-class, next-generation, non-steroidal mineralocorticoid receptor antagonist (MRA) being developed globally to initially treat patients with moderate-to-severe (Stage 3b/4) chronic kidney disease (CKD) and uncontrolled hypertension.

The Phase 2b clinical trial met its primary endpoint, with KBP-5074 demonstrating a clinically and statistically significant improvement in systolic blood pressure (SBP) from baseline to day 84 in Stage 3b/4 CKD patients with uncontrolled hypertension. The 0.5mg KBP-5074 cohort achieved a mean 10.1 mmHg reduction in SBP relative to the placebo cohort (p=0.0029), whereas the 0.25mg KBP-5074 cohort achieved a mean 7.0 mmHg reduction in SBP relative to the placebo cohort (p=0.0399). Importantly, and in contrast to other anti-hypertensive MRA drugs, KBP-5074 did not increase the risk of severe hyperkalemia compared to placebo. This finding is particularly notable given that the study included patients with stage 4 renal failure, who are normally contraindicated for use of MRA drugs.

Further, KBP-5074 demonstrated a clinically meaningful trend in the reduction of urine albumin-to-creatinine ratio (UACR). KBP-5074 also demonstrated a trend in reduction in diastolic blood pressure (DBP) from baseline to day 84 but such reduction was not statistically significant. KBP-5074 was observed to be well-tolerated in patients in the BLOCK-CKD trial with no observed cases of severe hyperkalemia, acute kidney injury or hospitalization due to hyperkalemia.

Dr. George Bakris, M.D., Director of the American Heart Association’s Comprehensive Hypertension Center at the University of Chicago Medical and co-lead investigator on the clinical trial, presented the results from the BLOCK-CKD trial on December 4, 2020 at the 17^th Global CVCT Forum in a session titled Hypertension Management in Advanced Chronic Kidney Disease. Results of the BLOCK-CKD Trial.

“We are excited to share the results from the BLOCK-CKD Phase 2b clinical trial of KBP-5074 for the treatment of Stage 3b/4 CKD patients with uncontrolled hypertension,” said Thijs Spoor, Chief Executive Officer of KBP Biosciences.

“These data further validate KBP-5074 as a potentially best-in-class therapy for patients with few, if any, viable options. They provide further evidence that MR antagonism with KBP-5074 can help advanced CKD patients with uncontrolled hypertension without significantly increasing the risk of hyperkalemia”, said Dr. George Bakris, M.D.

“We are extremely grateful to the investigators of the study, as well as the patients and their families for participating in the clinical trial. We look forward to meeting with the FDA in early 2021 to discuss the path forward for KBP-5074, including a Phase 3 clinical trial. With this new data, we are more confident than ever in the potential of KBP-5074,” said Dr. Bertram Pitt, MD Co-PI of the BLOCK-CKD clinical trial.

“We are committed to further advancing its development and bringing this drug to patients in-need,” said Fred Yang, Ph.D., Chief Development Officer of KBP Biosciences.

BLOCK-CKD is a randomized, double-blind, placebo-controlled, global, multi-center Phase 2b trial to assess the efficacy, safety and pharmacokinetics of KBP-5074 in patients with moderate-to-severe CKD with uncontrolled hypertension. The trial enrolled 162 patients with (i) an estimated Glomerular Filtration Rate (eGFR) of 15-44 mL/min/1.73m², (ii) SBP of 140-179 mmHg, (iii) a current treatment plan of two or more anti-hypertensive therapies; and (iv) a serum-potassium level less than or equal to 4.8 mmol/L at both screening and the end of the placebo run-in period.

Upon completion of a four-week screening period and two-week placebo run-in period, subjects were randomized to receive either placebo, 0.25mg, or 0.5mg doses of KBP-5074 once daily for twelve weeks, or 84 days, which was followed by a four-week post-treatment observation period. The primary endpoint of the trial was the change in trough-cuff seated SBP from baseline to day 84. The secondary endpoints, each from baseline to day 84, were the change in UACR and the change in the trough-cuff seated DBP.

“These top-line results of the BLOCK-CKD trial are promising for the large, global population of CKD patients with uncontrolled hypertension as well as KBP Biosciences,” said Dr. Bakris. “There is an extensive body of clinical data supporting the ability of MRAs to lower blood pressure, but they are contra-indicated in CKD patients due to the high risk of hyperkalemia. That KBP-5074 was able to significantly reduce blood pressure without causing dangerous elevations in potassium is highly encouraging and I look forward to further assessing its potential in the Phase 3 trial.”

About KBP Biosciences

KBP Biosciences is a global, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet needs. Headquartered in Princeton, NJ, KBP Biosciences principally devotes its resources to major organ protection and anti-infectives therapeutic areas.

KBP Biosciences’ lead product candidate, KBP-5074, is a potentially best-in-class, next-generation, non-steroidal MRA discovered and developed by KBP’s scientists, is being developed globally to initially treat Stage 3b/4, or moderate-to-severe, CKD patients with uncontrolled hypertension. KBP Biosciences second product candidate, KBP-7072, a potentially best-in-class, potent, broad spectrum aminomethylcycline, is being developed as an anti-infective for Gram-positive, Gram-negative and anaerobic bacteria, including multi-drug resistant pathogens.

KBP Biosciences has built a proprietary small-molecule drug discovery platform to advance its pipeline of product candidates. The platform includes state-of-the-art processes for novel drug compound identification, high-volume screening and optimization, along with our substantial library of over 3,000,000 diverse chemical entities and more than 30,000 bacterial isolates to identify and select potential compounds. With its discovery platform, KBP Biosciences is able to generate a multitude of drug compounds and quickly identify the most promising differentiated and potent product candidates.

Contacts:
Investors:
Tyler Ehler
Investor Relations
tyler.ehler@kbpbiosciences.com
+1 (929) 288-9573

Lee Roth
Burns McClellan
lroth@burnsmc.com
+1 (212) 300-8331

Media:
Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan
rimai@burnsmc.com / rflamm@burnsmc.com
+1 (212) 300-8315 / +1 (212) 300-8364