Boehringer Ingelheim Delivers Promising Results in Phase II Chronic Kidney Disease Trial

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Boehringer Ingelheim announced positive data from a 14-week study on 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. According to the company, it is the first clinical trial testing this novel treatment class on top of standard of care including empagliflozin in patients with chronic kidney disease (CKD), which effects more than 850 million people worldwide.¹

“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 Katherine Tuttle, MD, principal study investigator, professor of medicine in the nephrology division and Kidney Research Institute at the University of Washington, US, in a press release. “Additional CKD treatments are urgently needed to reduce residual risks of disease progression and serious complications.”

BI 690517, a novel, potent, highly selective ASi, was developed to inhibit the progression of kidney damage and decrease cardiovascular events in patients with CKD.

The study also found that while aldosterone synthase inhibition has the potential to moderate elevation of serum potassium, there is also a possibility that empagliflozin’s mechanism of action can mitigate the risk of hyperkalemia when given as a background therapy. The company believes that the effect is of high clinical importance due to the potential of severe hyperkalemia leading to changes in medical therapy or hospitalization.¹

In terms of safety, BI 690517 was generally well tolerated without unexpected events. Investigators noted modest dose-dependent increases in serum potassium levels with the novel therapy, which were slightly reduced by empagliflozin. Hyperkalemia was reported at a rate that is typical for patients with CKD, with most cases not requiring medical intervention or discontinuation of the drug.

CKD impacts more than 850 million individuals worldwide and can lead to kidney failure, dialysis, or transplantation, while elevating the risk of cardiovascular events and death. Researchers anticipate incidence rates for the condition to progressively increase in parallel with interconnected conditions, such as diabetes, hypertension, and obesity.

“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."

Reference

1. Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial. Boehringer Ingelheim. November 3, 2023. Accessed November 6, 2023. https://www.boehringer-ingelheim.com/promising-phase-ii-results-chronic-kidney-disease