Aldosterone synthase inhibitor shows promise in CKD trial: Boehringer Ingelheim

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

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. 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%.

“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-KIDNEY trial will begin recruitment. The trial aims to definitively test the efficacy and safety of BI 690517 given on top of standard of care, including empagliflozin. EASi-KIDNEY will recruit and follow about 11,000 participants with established CKD, at risk of kidney disease progression, using Oxford Population Health’s streamlined model.

BI 690517 was generally well tolerated without unexpected safety signals. 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, and most episodes did not require medical treatment or BI 690517 discontinuation.

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