Bayer to Initiates P-III Study (FINE-ONE) of Finerenone for the Treatment of Chronic Kidney Disease and Type 1 Diabetes
Shots:
- The company will initiate the P-III study (FINE-ONE) to evaluate the safety & efficacy of finerenone + SoC vs PBO in a ratio (1:1) in ~220 adults. The primary objective of the study is to demonstrate the superiority of finerenone over PBO in reducing urine albumin to creatinine ratio (UACR) over 6mos.
- In the prespecified FIDELITY pooled analysis of the P-III studies (FIDELIO-DKD) & (FIGARO-DKD), finerenone showed a reduction in the risk of CKD progression, fatal and nonfatal CV events & also showed a consistent & sustained reduction in UACR by ≥30%
- Finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist is marketed as Kerendia or in some countries as Firialta, and was approved for CKD associated with T2D in 70+ countries globally
Ref: Bayer | Image: Bayer
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