BI 690517 ,an aldosterone synthase inhibitor on top of empagliflozin, showed a significant reduction of albuminuria,a marker of kidney damage in Phase II trial. - Boehringer.
Boehringer Ingelheim 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, by up to 39.5% when BI 690517 was given on top of empagliflozin, a sodium glucose cotransporter (SGLT2) inhibitor, vs. placebo. 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), which affects more than 850 million people worldwide. The findings were presented as a high-impact clinical trial at the American Society of Nephrology (ASN)’s Kidney Week 2023.
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 (greater than 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%.
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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