PR99958

PRINCETON, N.J., April 18, 2023 /PRNewswire=KYODO JBN/ --

EMJ Nephrology interviewed two World-renowned experts in nephrology and

cardiology, George Bakris and Faiez Zannad, regarding the challenges of

treating uncontrolled hypertension (uHTN) in patients with advanced chronic

kidney disease (CKD), a large unmet need for safe, effective therapies, and the

potential of one therapy, Ocedurenone, to address this need.

Original article: EMJ-8.1-2023-1.pdf

(emg-health.com)<https://emj.emg-health.com/wp-content/uploads/sites/2/2023/03/E

MJ-8.1-2023-1.pdf>

Large Unmet Need

Patients with advanced CKD have a high burden of disease, compounded by serious

comorbidities, most commonly hypertension. Controlling hypertension is vital in

these patients to reduce the associated risks of morbidity and mortality, as

well as reducing cardiorenal risk, but treatment options are limited due to

safety concerns with the use of existing agents.

Current Options

Bakris:"The PATHWAY-2 trial showed that in people with resistant hypertension

without advanced CKD, spironolactone produced a greater reduction in blood

pressure than a β- blocker and an α- blocker. However, it presents

safety risks to patients when administered."

"Then there is eplerenone, given twice a day, while safe, has a much weaker

effect on blood pressure reduction than spironolactone. That's all we've got,

so that's what people use."

Dr Bakris also mentioned two existing nonsteroidal MRAs, esaxerenone which is

"approved exclusively in Japan, for which there are no placebo-controlled

comparisons", and Finerenone which "reduces blood pressure (placebo subtracted)

variously from 3 mmHg (ARTS-DN, FIGARO-DKD, and FIDELIO-DKD studies) to

approximately 8 mmHg (subset analysis from ARTS-DN study, eGFR of approximately

68, though office blood pressure from the same study showed around 3 mmHg

reduction)".

Future Option - Ocedurenone

Bakris:"Now, Ocedurenone, a non-steroidal MRA, shows clear promise in patients

whose standard of care includes two, three, or more drugs. Ocedurenone is the

only drug that has consistently steadied resistant hypertension in people with

advanced CKD."

In the first dedicated study of patients with uncontrolled hypertension and

advanced CKD (BLOCK-CKD), Ocedurenone demonstrated efficacy in lowering blood

pressure, together with a favorable safety profile. The experts were optimistic

that it could provide a much-needed treatment option for these patients, with

the added potential for reduction in the risk of cardiorenal outcomes.

"This study showed that Ocedurenone reduces SBP by 11 mmHg

(placebo-subtracted), a reduction that could lead to potential approval. No

other agent to date has steadied blood pressure as well in this group of

patients. And the point is that these are the patients who need the most help."

Zannad reinforced the importance of the hyperkalemia data for the clinical

safety of Ocedurenone:"With Ocedurenone, we may for the first time have an MRA

that is both safe and efficacious."

Bakris added:"A Phase 3 study (CLARION-CKD) of Ocedurenone in a similar patient

population is ongoing. I remain optimistic that the signal seen in the

BLOCK-CKD study will be seen in this larger study."

"I remain excited about Ocedurenone. Its tolerability and efficacy in lowering

blood pressure in a very high-risk group will have a significant impact on

morbidity."

"Mineralocorticoid receptors are so ubiquitous which may allow for indications

beyond CKD and cardiovascular conditions. This is likely just the beginning for

Ocedurenone."

About Ocedurenone (KBP-5074)

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 medical needs.

Ocedurenone (KBP-5074) is a non-steroidal MRA discovered and developed by KBP

Biosciences. At present, the Phase 3 clinical trial of the first indication for

Ocedurenone, advanced CKD and uncontrolled hypertension, is underway.

About KBP Biosciences, please visit https://www.kbpbiosciences.com/.

SOURCE  KBP Biosciences