German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) on Friday reported full results from the Phase III FIND-CKD trial evaluating Kerendia (finerenone) in adults with non-diabetic chronic kidney disease (nd-CKD).
The study demonstrated a significant reduction in kidney disease progression, measured by estimated glomerular filtration rate slope, versus placebo.
Kerendia also achieved a statistically significant reduction in a composite kidney-cardiovascular endpoint, including kidney failure, sustained eGFR decline of at least 57%, hospitalisation for heart failure, or cardiovascular death. The safety profile was consistent with prior Phase III studies, with serious adverse event rates of 20.9% for Kerendia and 21.2% for placebo.
The randomised, double-blind trial enrolled 1,584 participants receiving standard of care alongside either Kerendia or placebo, including background therapy with ACE inhibitors or ARBs. The results represent the fifth consecutive Phase III trial in which Kerendia met its primary endpoint, contributing to a broader programme of more than 20,000 patients across cardiovascular and kidney disease populations.
Kerendia is currently approved by the US FDA for chronic kidney disease associated with type 2 diabetes and for heart failure with left ventricular ejection fraction of 40% or greater.
The FIND-CKD data were presented at the 63rd European Renal Association Congress in Glasgow and published in the New England Journal of Medicine.
IceCure reports growing adoption of ProSense cryoablation in Brazil
Aurinia initiates PRESERVE Phase 4 study of LUPKYNIS combination therapy in lupus nephritis
Genentech reports positive Phase III results for divarasib in KRAS G12C lung cancer
Neurocrine Biosciences initiates crinecerfont Phase 2 study in young children with classic CAH
PharmaResearch to acquire CG USA to support North American expansion of REJURAN Cosmetics
Hansa Biopharma closes EUR115m Licensing Deal with SERB Pharmaceuticals for Idefirix
SciBase submits FDA filing to expand Nevisense use to non‑melanoma skin cancers
Galderma receives FDA Complete Response Letter for RelabotulinumtoxinA US filing
AbbVie receives positive CHMP opinion for upadacitinib in severe alopecia areata
AbbVie receives positive CHMP opinion for upadacitinib in non‑segmental vitiligo
genedrive partners with Thermo Fisher Scientific to develop high-throughput CYP2C19 test