Boehringer's aldosterone synthase inhibitoraldosterone synthase inhibitor shows promise in CKD trial

03 Nov 2023
firstwordpharma.com
Clinical ResultPhase 2Drug ApprovalPhase 3
Boehringer Ingelheim announced on Friday that 14-week Phase II trial data showed a significant reduction by up to nearly 40% of albuminuria in patients with chronic kidney disease (CKD) when its aldosterone synthase inhibitor BI 690517 was given on top of SGLT2 inhibitor Jardiance (empagliflozin) compared to placebo.  The results were presented at the American Society of Nephrology (ASN) Kidney Week meeting.
"Using BI 690517 along with SGLT2 inhibition may offer the potential for additive kidney benefits while possibly mitigating hyperkalaemia risk," said principal investigator Katherine Tuttle.
The trial assessed the efficacy and safety of multiple oral doses of BI 690517 alone or on top of Jardiance in 714 people with CKD, with or without type 2 diabetes, receiving stable background therapy with an angiotensin receptor blocker or angiotensin-converting enzyme inhibitor.
Participants were first randomised to receive either Jardiance or placebo for eight weeks, then 586 of the participants were randomized a second time to receive a 3 mg, 10 mg or 20 mg dose of BI 690517 or placebo for 14 weeks. The primary endpoint was the efficacy of BI 690517 measured by the percentage change in urine albumin creatinine ratio (UACR) from the second randomization to end of treatment.
Significant albuminuria reductions versus placebo were achieved when BI 690517 was given on top of Jardiance for all doses. The greatest UACR reduction was among the participants receiving the 10mg dose on top of Jardiance. The reductions were 39.5%, 33.2% and 9.4% for the 10mg, 20 mg and 3mg doses. Significant albuminuria reductions versus placebo were also achieved when BI 690517 was given without Jardiance, of 37.4%, 34.9% and 20.3%, for the 10mg, 20 mg and 3mg doses.
Key secondary endpoint
A clinically meaningful reduction in UACR (≥30%), a key secondary endpoint, was achieved by up to 70% of patients treated with BI 690517 on top of Jardiance, which the company said may translate into risk reductions for CKD events by at least 30%.
Boehringer said it will begin recruitment next year of its Phase III EASi-KIDNEY trial, which aims to definitively test the efficacy and safety of BI 690517 given on top of standard of care, including empagliflozin, in about 11,000 participants with established CKD at risk of progression.
The FDA approved Boehringer and Eli Lilly's Jardiance in September to reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalisation in adults with CKD at risk of progression.
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