Bayer trial combines two top drugs for kidney disease

The combination of Bayer's mineralocorticoid receptor antagonist (MRA) finerenone and Boehringer Ingelheim and Eli Lilly's SGLT2 inhibitor Jardiance works better than either drug used alone in patients with chronic kidney disease (CKD) associated with type 2 diabetes.

That is the finding of the phase 2 CONFIDENCE trial, presented at the European Renal Association (ERA) congress and simultaneously published in the New England Journal of Medicine, that, according to Bayer, could "deliver a substantial and early [improvement in] long-term outcomes for millions of patients worldwide."

In the study, patients receiving the combination therapy saw a 52% reduction in urine albumin-to-creatinine ratio (UACR), a biomarker for kidney damage, after 180 days of treatment.

That was a 29% and 32% greater relative reduction in UACR, respectively, compared to Kerendia and Jardiance given alone, and easily exceeded the recommendation by the American Diabetes Association (ADA) to try to achieve a 30% or greater reduction in the biomarker to slow progression of CKD.

The results showed that nearly three out of four patients taking the dual regimen achieved that threshold, 20% more than with either treatment alone, and there were no side effects other than those that are already recognised with the two drugs.

Finerenone is already on the market as Kerendia (and Firialta in some markets) for CKD associated with type 2 diabetes, and is one of Bayer's top growth prospects, with sales rising 89% in the first quarter of this year to almost $180 million.

Bayer has sales expectations of $3 billion or more for the drug, fuelled mainly by a recently filed follow-up indication in a common form of heart failure, but the combination could also help to drive growth as Jardiance (empagliflozin) has become a cornerstone therapy for CKD after getting approved for the indication in 2023.

The CONFIDENCE data is also an early sign that a follow-up trial called CONFIRMATION-HF – testing the Kerendia/Jardiance combination in patients hospitalised or recently discharged with heart failure – will also have a positive readout.

Rajiv Agarwal of Indiana University School of Medicine and VA Medical Center, who chaired the study's steering committee, said the data "provide key insights to clinicians when considering how to optimise disease management, supporting the early combined use of finerenone and an SGLT-2 inhibitor for a positive impact on patient outcomes."

Type 2 diabetes affects an estimated 462 million people globally, of whom around 40% go on to develop CKD.