Tokyo - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the primary objective has been achieved from ESAX-DN, a Phase 3 pivotal study of esaxerenone, a non-steroidal, selective novel mineralocorticoid receptor (MR) blocker, for patients in Japan with diabetic nephropathy.
The ESAX-DN results were presented in a late-breaking presentation during Kidney Week 2019, the annual meeting of the American Society of Nephrology, in Washington, USA.
ESAX-DN is a phase 3 randomized, double-blind, 2-arm, parallel group comparison study with placebo in incipient diabetic nephropathy patients1 who are taking an angiotensin II receptor blocker (ARB) or an angiotensin converting enzyme (ACE) inhibitor in Japan.
The study showed the esaxerenone-based regimen had a significantly higher Urine Albumin-to-Creatinine Ratio (UACR) remission2 rate (esaxerenone: 22.1% vs. placebo: 4.0%) and significantly reduced UACR (esaxerenone:-58.3% vs. placebo: 8.3) compared with the placebo group. As the secondary endpoint, significant reduction of progression from incipient to overt diabetic nephropathy3 (esaxerenone: 1.4%vs. placebo: 7.5%) was confirmed in the esaxerenone group compared to the placebo group.
Additionally, no new safety concerns were identified in this study. 8.8% of confirmed hyperkalemia was observed in the esaxerenone group compared with 2.2% in the placebo group, and elevated serum potassium was recovered after discontinuation of administration.
Daiichi Sankyo will further contribute to medical care by using the scientific knowledge around esaxerenone, which has been expanded through the ESAX-DN study results.
Incipient diabetic nephropathy means type 2 diabetes with microalbuminuria, which is defined 45UACR300 mg/gCr in this study.
Satisfying both reversal to normal range of UACR, which is an index of kidney function, and sustainment; defined as achieving two consecutive UACR
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