Daiichi Sankyo has reported positive data from the Phase III clinical trial of esaxerenone to treat patients with incipient diabetic nephropathy, which is type 2 diabetes with microalbuminuria, in Japan.
Esaxerenone is an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR). The drug is believed to have the potential to prevent organ damage driven by aldosterone.
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The drug was identified as part of Daiichi Sankyo’s research collaboration with Exelixis.
During the Phase III ESAX-DN trial, esaxerenone was compared to placebo in a total of 455 type 2 diabetes patients with microalbuminuria.
The study enrolled patients taking an angiotensin II receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor at 135 sites in Japan.
The primary endpoint of the randomised, double-blind, two-arm, parallel-group trial was the rate of remission to normoalbuminuria after treatment for 52 weeks.
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By GlobalDataParticipants were also evaluated for change rate in urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) as secondary endpoints.
Daiichi Sankyo said that ESAX-DN met the primary objective. The esaxerenone-based regimen showed a significantly higher UACR remission rate of 22.1% and decreased UACR by 58.3%, compared to 4% and 8.3%, respectively, with placebo.
Furthermore, patients treated with the investigational drug had a significant decrease in progression from incipient to overt diabetic nephropathy, which is type 2 diabetes with UACR.
Investigators did not report any new safety concerns during the trial. Confirmed hyperkalaemia was 8.8% in patients on esaxerenone and 2.2% in the placebo arm.
The company noted the recovery of increased serum potassium following the discontinuation of treatment.
A company statement said: “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.”
The company presented the Phase III data at the annual meeting of the American Society of Nephrology held in Washington, US.
