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.
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.
Participants 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.