Bayer reports FINE-ONE trial met primary endpoint

Bayer (BAYRY) announced new Phase III investigational data from the pivotal FINE-ONE trial showing that Kerendia significantly reduced urine albumin-to-creatinine ratio from baseline over six months by 25% compared to placebo in patients with type 1 diabetes and chronic kidney disease who were receiving standard of care. These late-breaking data were presented at the opening plenary session of the American Society of Nephrology Kidney Week 2025 in Houston. The investigational FINE-ONE trial met its primary endpoint, demonstrating that finerenone led to a significant reduction in urine albumin-to-creatinine ratio, an important marker of cardiovascular risk and kidney disease progression, from start of trial through six months, for people living with type 1 diabetes and chronic kidney disease versus those receiving standard of care plus placebo. These data were presented as a late-breaker at the opening plenary session at the American Society of Nephrology Kidney Week 2025. Additionally, three presentations from the CONFIDENCE trial in patients with type 2 diabetes and CKD, which investigated simultaneous administration of finerenone and a sodium-glucose transport protein 2 inhibitor will also be presented as two late-breaking analyses and featured independently as part of the “Best of the Journal of the American Medical Association and the New England Journal of Medicine” session. In FINE-ONE, safety and tolerability with finerenone were largely consistent with the existing evidence for people with T2D and CKD. The rate of treatment-emergent adverse events was 47.1% for those treated with finerenone and 49.2% for placebo. The rate of treatment-emergent serious adverse events was 11.8% and 11.5%, respectively. Hyperkalemia, an adverse event of special interest, was observed more frequently with finerenone compared to placebo. The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively. Bayer plans to submit a supplemental New Drug Applicationto the U.S. FDA based on the results of FINE-ONE in 2026.