Daiichi Sankyo announces positive results from Phase 3 pivotal trial
Category: #health  By Saipriya Iyer  Date: 2019-11-11
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Daiichi Sankyo announces positive results from Phase 3 pivotal trial

Daiichi Sankyo Company, Limited (hereafter Daiichi Sankyo), today made a breakthrough announcement stating that the main objective has been achieved from ESAX-DN—a phase 3 pivotal study of esaxerenone—a product of the companies’ previously undertaken research collaboration meant for patients in Japan with diabetes nephropathy.

For the uninitiated, Esaxerenone, pioneered and commercialized by Daiichi Sankyo, is a novel mineralocorticoid receptor (MR) blocker recognized during the research collaboration between Exelixis and Daiichi Sankyo. Palpable development and commercialization of esaxerenone is credited to Daiichi Sankyo. The company found an apt partner in Exelixis to decrease royalties on sales and propel commercialization.

ESAX-DN is a phase 3 randomized, 2 armed, double-blind, parallel group comparison study with placebo in incipient diabetes nephropathy, who are consuming an angiotensin converting enzyme (ACE) inhibitor or angiotensin II blocker (ARB) in Japan.

The study succinctly revealed that the esaxerenone-based regimen had conspicuously higher UACR remission*2 rate (22.1% vs placebo: 4.0%). The esaxerenone-based regimen also notably reduced UACR (esaxerenone: -58.3% vs placebo: 8.3%) compared with the placebo group. With secondary endpoint, considerable plunge of progression from incipient to overt diabetic nephropathy*3 (esaxerenone: 1.4% vs placebo: 7.5%) was observed in the esaxerenone group vis-à-vis placebo group.

Reportedly, no safety issues were detected in in the study; 8.8% of confirmed hyperkalemia was witnessed in esaxerenone group, as compared with 2.2% in the placebo group.

Diabetic Nephropathy in Japan

When it comes to lingering morbidity and mortality for individual patients with diabetes, diabetic nephropathy has apparently been one of the most lethal long-term complications. Reportedly, 12.1% of the population in Japan, or around 10 million people, are anticipated to have diabetes. Alarmingly, experts predict evidence of diabetic nephropathy among 50% of all type 2 diabetics. When it came to the most common cause for patient needing dialysis treatment as of 2017, diabetes topped the list with 42.5%.

Health governing bodies in Japan recommend multifactorial intensive therapy, including control of blood pressure, lipid and blood glucose and using ACE or ARB inhibitor in the treatment guidelines to dissipate the creation and development of early diabetic nephropathy.

Source Credits:

https://ir.exelixis.com/news-releases/news-release-details/exelixis-collaborator-daiichi-sankyo-announces-positive-results



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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