Bayer has added three investigator-sponsored Phase III clinical trials evaluating Kerendia (finerenone) for the treatment of heart failure.
Kerendia is one of Bayer’s best-selling drugs, with reported sales of €67m ($72.6m) in Q2 2023, as per the company’s half-year report. GlobalData expects the sales to grow up to $1.4bn in 2029.
GlobalData is the parent company of Clinical Trials Arena.
Kerendia has been approved by the US Food and Administration (FDA) for reducing the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalisation for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
The studies will receive sponsorship from the non-profit academic research organisation CPC Clinical Research, with funding from Bayer.
The three Phase III trials include two placebo-controlled, randomised REDEFINE-HF study (NCT06008197) and FINALITY-HF evaluating Kerendia monotherapy, and one open-label CONFIRMATION-HF trial evaluating Kerendia in combination with a sodium-glucose co-transporter-2 (SGLT2) inhibitor.
The trials will add to the existing Phase III (NCT04435626) placebo-controlled trial. Bayer expects to enrol about 15,000 patients across the four trials.
The focus on expanding Kerendia’s label expansion is in line with Bayer’s strategy to focus on four core areas, namely cardiovascular, neurology, oncology, and rare diseases/immunology.
Recently, Bayer signed a trial collaboration and supply agreement with Celcuity to supply Nubeqa (darolutamide) free of charge for a combination therapy trial with the latter’s pan-PI3K/mTOR inhibitor, gedatolisib, for the treatment of non-metastatic castration-resistant prostate cancer.
