Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial

Phase II results demonstrated significant albuminuria reductions by up to 39.5% vs. placebo when BI 690517, a novel selective aldosterone synthase inhibitor, was given on top of empagliflozin, an SGLT2 inhibitor, suggesting additive efficacy[1]

Potential new treatment builds on Boehringer Ingelheim’s leadership in the field of cardio-renal-metabolic conditions and will be further investigated in a Phase III clinical trial program, EASi-KIDNEYTM, together with Oxford Population Health[1]

First-in-class Phase II data in chronic kidney disease from BI 690517 were presented as a high-impact clinical trial at the American Society of Nephrology (ASN)’s Kidney Week 2023[1]

News provided by
Boehringer Ingelheim
Nov. 05, 2023 10:20
INGELHEIM, GERMANY--(Business Wire / Korea Newswire)--Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi). The results showed a significant reduction of albuminuria, a marker of kidney damage,[2] by up to 39.5% when BI 690517 was given on top of empagliflozin, a sodium glucose cotransporter (SGLT2) inhibitor, vs. placebo.[1] This is the first clinical trial testing this novel treatment class on top of standard of care including empagliflozin in people with chronic kidney disease (CKD),[1] which affects more than 850 million people worldwide.[3] The findings were presented as a high-impact clinical trial at the American Society of Nephrology (ASN)’s Kidney Week 2023.[1]

BI 690517 has a novel mode of action that effectively and sustainably inhibits aldosterone synthase, an enzyme that controls the final rate-limiting steps in aldosterone synthesis.[1],[4] Excessive aldosterone levels cause organ damage and promote cardio-renal-metabolic conditions such as hypertension, chronic kidney disease or heart failure.[5]

“This unique trial testing a selective aldosterone synthase inhibitor on top of standard of care including SGLT2 inhibition, showed positive and clinically relevant efficacy. Using BI 690517 along with SGLT2 inhibition may offer the potential for additive kidney benefits while possibly mitigating hyperkalemia risk,” said Dr Katherine Tuttle, Principal Study Investigator and Professor of Medicine in the Nephrology Division and Kidney Research Institute at the University of Washington, U.S. “Additional CKD treatments are urgently needed to reduce residual risks of disease progression and serious complications.”

While aldosterone synthase inhibition can lead to moderate elevation of serum potassium,[6] this study suggests there is potential that empaglifozin’s mechanism of action can mitigate the risk of hyperkalemia when given as a background therapy.[7],[8] This effect is of high clinical importance since severe hyperkalemia may lead to changes in medical therapy or hospitalization.[9] As a novel drug class, BI 690517, on top of empagliflozin, may address this critical unmet medical need.[1]

A key secondary endpoint in the Phase II trial was a clinically meaningful reduction in UACR (≥30%) which was achieved by up to 70% of patients treated with BI 690517 on top of empagliflozin.[1] Based on analyses assessing albuminuria change as a predictive indicator, these changes may translate into risk reductions for clinical kidney disease events by at least 30%.[1]

“These encouraging Phase II data not only demonstrate our commitment to developing innovative and transformational treatments for people living with cardio-renal-metabolic conditions but also have the potential to decrease the global burden of these interconnected diseases,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “With over 1 billion people worldwide affected by these conditions, the potential to help reduce the pressure on healthcare systems and patients is immense. We are proud to be leading the way in this field and are excited to move forward with the upcoming Phase III trial to further investigate the potential of this novel compound on top of standard of care including empagliflozin.”

In 2024, Oxford Population Health and Boehringer Ingelheim’s new, international Phase III EASi-KIDNEYTM trial will begin recruitment.[1] The trial aims to definitively test the efficacy and safety of BI 690517 given on top of standard of care, including empagliflozin.[1] EASi-KIDNEYTM will recruit and follow about 11,000 participants with established CKD, at risk of kidney disease progression, using Oxford Population Health’s streamlined model.[1]

BI 690517 was generally well tolerated without unexpected safety signals.[1] Dose-dependent modest increases in serum potassium levels were observed with BI 690517, which were slightly ameliorated in the presence of empagliflozin. Hyperkalemia occurred at a rate typical for a CKD population,[1] and most episodes did not require medical treatment or BI 690517 discontinuation.[1]

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