Bayer Launches Phase 3 FIONA Study of Kerendia (finerenone) in Pediatric Patients with Chronic Kidney Disease; Regulatory Review Underway in China

News on November 22, 2021 /BioValleyBIOON/ --BayerBayer recently announced the launch of the Phase 3 FIONA study, a multicenter, randomized, double-blind, placebo-controlled study that will evaluateKerendia (finerenone) in combination with standard care for the treatment of pediatric patients with chronic kidney disease (CKD) and severely increased proteinuriaThe efficacy, safety, pharmacokinetics/pharmacodynamics (PK/PD) of Kerendia. The primary objective of this study is to demonstrate that in pediatric patients, when combined with standard care (angiotensin-converting enzyme [ACE] inhibitors or angiotensin II receptor blockers [ARBs]), Kerendia is superior to placebo in reducing urinary protein excretion. The primary endpoint is the change in the urine protein-to-creatinine ratio (UPCR) from baseline to 6 months.

"Heidelberg University Hospital Professor of Pediatrics and Head of the Pediatric Nephrology Department, Dr. Franz Schaefer, stated: 'In pediatric patients, chronic kidney disease (CKD) is a rare but highly devastating condition that affects children of all age groups. Despite some progress achieved through prior research, children with this disease still experience disease progression and proteinuria — a significant and modifiable risk factor for declining kidney function. New treatment approaches are needed to target this risk factor while working in synergy with current therapies. If successful, the insights from this research will hold substantial importance for children with CKD and their families.'"

Finerenone Chemical Structure (Image Source: newdrug)approvals.org）

Proteinuria is an important and modifiable risk factor for CKD progression in pediatric patients.Aldosterone-mediated activation of renal mineralocorticoid receptor (MR) drives a vicious cycle by promoting tissue inflammation and damage.Finerenone is a non-steroidal, selective MR antagonist. Preclinical studies have shown that the drug can block the harmful effects of excessive MR activation, which is considered to drive the progression of CKD and cardiovascular damage.

Through two completed Phase III studies (FIDELIO-DKD, FIGARO-DKD), finerenone inExtensive stages 1-4 CKD and type 2Diabetes(T2D) Adult PatientsConducted research. In these studies,Finerenone benefits renal and cardiovascular outcomes in CKD and T2D patients and demonstrates consistent safety across all studies.FIDELITY is a pre-specified pooled analysis of more than 13,000 patients with CKD and T2D from the FIDELIO-DKD and FIGARO-DKD studies, evaluating the potential benefits of finerenone across the disease spectrum through renal disease progression and the occurrence of fatal and non-fatal cardiovascular events. The FIDELITY analysis shows,Finerenone benefits cardiovascular and renal outcomes in a broad population of CKD patients with T2D.

Christian Rommel, Ph.D., Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development, stated: "In the largest study to date on chronic kidney disease (CKD) and type 2Diabetes(Phase 3 of T2D)Clinical TrialIn the project (including more than 13,000 adult patients), finerenone has demonstrated the potential to improve renal and cardiovascular outcomes. The new FIONA study extends our clinical research on finerenone to children and adolescents with CKD, where there is a significant unmet medical need for new therapies that can slow disease progression and preserve kidney function for as long as possible.”

Finerenone Mechanism of Action (Image Source: researchgate.net)

Kerendia (finerenone) is a first-in-class, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that reduces the harmful effects of overactivation of the mineralocorticoid receptor (MR). Overactivation of MR can lead to inflammation and fibrosis, which are key drivers of CKD progression and cardiac damage.

July 2021, United StatesFDAApproval of Kerendia for the treatment of chronic kidney disease (CKD) with type 2 diabetesDiabetes(Adult patients with T2D), reducing the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease (ESKD), cardiovascular death, non-fatal myocardial infarction, and heart failure hospitalization. Kerendia was approved through the priority review process. Currently, the drug is alsoCurrently being accepted by the EU and ChinaAnd regulatory reviews in some other countries.

It is worth mentioning that,Kerendia is the first non-steroidal, selective MRA to demonstrate positive renal and cardiovascular outcomes in CKD patients with T2D.Despite guideline-directed therapies, many patients with CKD and T2D still progress to kidney failure and remain at high risk for cardiovascular events. Kerendia's mechanism of action is distinct from existing therapies; by blocking the overactivation of MR, the drug directly targets inflammation and fibrosis to slow disease progression. (Bioon.com)

Source of the original text:Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease