Japanese pharmaceutical firm Daiichi Sankyo has started a Phase III clinical trial (ESAX-DN) of its product candidate esaxerenone to treat diabetic nephropathy in the country.

Esaxerenone is a non-steroidal, selective blocker of mineralocorticoid receptor (MR) being developed as part of a research collaboration agreement between Daiichi Sankyo and US-based drug company Exelixis.

The randomised, double-blind, two-arm, parallel group Phase III trial is designed to evaluate esaxerenone in 400 type 2 diabetes patients at around 130 trial sites.

ESAX-DN will enrol patients who have microalbuminuria and are receiving an angiotensin II receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor.

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The primary endpoint of the trial is rate-of-remission to normoalbuminuria following treatment for 52 weeks, while the secondary endpoints are change rate in urinary albumin creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR).

Daiichi Sankyo has also reported positive top-line data from the Phase III ESAX-HTN trial of esaxerenone for the treatment of essential hypertension in the country.

“The results demonstrated no significant safety concerns during the randomised, double-blind, three-arm, parallel group trial when compared to eplerenone as active control.”

The results demonstrated no significant safety concerns during the randomised, double-blind, three-arm, parallel group trial when compared to eplerenone as active control.

With 1,001 subjects at 44 clinical centres, the trial’s primary endpoint was sitting systolic blood pressure (SBP) / diastolic blood pressure (DBP) change from baseline following 12-week treatment.

The secondary endpoint included mean change in 24-hour SBP / DBP from baseline after treatment for 12 weeks.

In a previous Phase II trial, 2.5mg a day and 5mg a day of esaxerenone demonstrated a significant decrease in sitting SBP / DBP.

Image: Nodular glomerulosclerosis in the kidney of a patient with diabetic nephropathy. Photo: courtesy of Centres for Disease Control and Prevention.