Boehringer Ingelheim said that its BI 690517 on top of empagliflozin has shown a reduction in albuminuria, a marker of kidney damage, in the Phase 2 trial of people with chronic kidney disease (CKD).
BI 690517 is said to be a potent, highly selective aldosterone synthase inhibitor (ASi). It is designed to lower cardiovascular events in CKD patients and slow the progression of kidney damage.
Empagliflozin is a sodium-glucose cotransporter (SGLT2) inhibitor.
The Phase 2 trial assessed BI 690517 on top of empagliflozin against a placebo for 14 weeks.
The promising data demonstrated significant albuminuria reductions by up to 39.5%.
A key secondary endpoint of the Phase 2 study was a clinically significant decrease in UACR (≥30%), which was attained by up to 70% of patients receiving BI 690517 in addition to empagliflozin treatment.
According to the German pharmaceutical company, the changes may result in at least a 30% lower risk of clinical renal disease events, based on analyses assessing albuminuria change as a predictive indicator.
Boehringer Ingelheim Human Pharma head Carinne Brouillon said: “These encouraging phase 2 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.
“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 3 trial to further investigate the potential of this novel compound on top of standard of care including empagliflozin.”
The Phase 2 study was a placebo-controlled, double-blind trial that evaluated the efficacy and safety of multiple oral doses of BI 690517 alone or on top of an SGLT2 inhibitor.
The primary endpoint was defined as the efficacy of BI 690517 by measuring the percentage change in urine albumin creatinine ratio.
Oxford Population Health and Boehringer Ingelheim will start recruiting 11,000 patients for the new global phase 3 EASi-KIDNEY trial in 2024.
