Boehringer Ingelheim’s BI 690517 shows up to 39.5% albuminuria reduction in Phase II trial

Boehringer Ingelheim has revealed promising results from its 14-week Phase II trial for BI 690517, a novel selective aldosterone synthase inhibitor. The data highlights a substantial up to 39.5% reduction in albuminuria when BI 690517 is used in conjunction with empagliflozin, an established SGLT2 inhibitor, compared to a placebo. This study represents the first of its kind, testing this new treatment class on top of standard care, including empagliflozin, for individuals with chronic kidney disease—a condition affecting over 850 million people globally. The findings were notably shared at Kidney Week 2023, hosted by the American Society of Nephrology.

Boehringer Ingelheim’s BI 690517 targets aldosterone synthase, effectively curtailing the production of aldosterone, which in excess, leads to significant organ damage and exacerbates conditions like hypertension, CKD, or heart failure. Dr. Katherine Tuttle, the principal study investigator, underscored the significance of combining the aldosterone synthase inhibitor with SGLT2 inhibition, hinting at enhanced renal protection and the possibility of reduced hyperkalemia risks. This combination therapy approach by Boehringer Ingelheim could herald a new era in CKD management, aiming to lessen the disease’s progression and its severe complications.

The Phase II trial not only showcased a marked decrease in albuminuria but also demonstrated that up to 70% of patients attained a clinically meaningful reduction in UACR (urinary albumin-to-creatinine ratio). These improvements are considered predictive of a lowered risk for future clinical kidney events by at least 30%, according to the trial analyses.

Carinne Brouillon, Head of Human Pharma at Boehringer Ingelheim, reflected on the Phase II data, stressing the company’s commitment to pioneering innovative treatments for cardio-renal-metabolic conditions and potentially easing the global healthcare burden.

Looking ahead to 2024, Boehringer Ingelheim, in partnership with Oxford Population Health, is preparing for the international Phase III EASi-KIDNEY trial. This forthcoming trial aims to conclusively assess the efficacy and safety of BI 690517 atop the standard of care, including empagliflozin, with about 11,000 participants with established CKD to be recruited.

BI 690517 was well received in the trials, displaying good tolerance and manageable serum potassium levels, even when combined with empagliflozin. Hyperkalemia occurrences were consistent with those typical in CKD populations, with most cases not necessitating medical intervention or discontinuation of BI 690517, marking another stride in Boehringer Ingelheim’s journey towards transforming CKD treatment.