Germany-based Boehringer Ingelheim (BI) has published the results of a Phase II trial for its aldosterone synthase inhibitor (ASi) BI 690517, used alone or in combination with the antidiabetic Jardiance (empagliflozin), in patients with chronic kidney disease (CKD), with or without type 2 diabetes (T2D). The trial aimed to evaluate the drug’s novel mode of action in preventing cardiorenal damage associated with high aldosterone levels, while managing the side effect of hyperkalemia through the addition of the SGLT2 inhibitor Jardiance.
Trial Results and Efficacy
According to the press release, the combination therapy achieved a reduction in urine albumin-to-creatinine ratio (UACR), a measure of albuminuria, by 30% or more in up to 70% of participants. The placebo-corrected percentage change in UACR for the low, middle, and high doses after 14 weeks were -9.4%, -39.5%, and -33.2%, respectively. These results suggest an additive efficacy for the drug pairing, encouraging BI to progress the therapy to Phase III.
Competition in CKD Treatment
The announcement follows closely on the heels of news from UK company AstraZeneca (AZ; NASDAQ: AZN), which revealed that its ETA receptor antagonist and SGLT2 inhibitor combination, zibotentan + dapagliflozin, achieved a mean change from baseline in UACR of -52.5% in the high-dose group of a similar middle-stage study in CKD. Notably, AstraZeneca’s regimen was 2 weeks shorter than BI’s protocol, highlighting the competitive landscape in the development of novel treatments for CKD.-Fineline Info & Tech
