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-- Results being presented today in a late-breaking presentation (abstract TH-PO1201) at Kidney Week 2019, the annual meeting of the
Esaxerenone is a novel mineralocorticoid receptor (MR) blocker identified during the prior research collaboration between
“The ESAX-DN study is the second successful phase 3 pivotal trial our collaborators at
The study showed that the esaxerenone-based regimen resulted in a significantly higher UACR remission rate† (22.1% versus 4.0%) as compared to placebo. The esaxerenone-based regimen also significantly reduced UACR (-58.3% versus +8.3%) and was associated with a significant reduction in progression from incipient to overt diabetic nephropathy‡ as compared to placebo (1.4% versus 7.5%).
Investigators reported that no new safety concerns were identified in the study. In the esaxerenone group, 8.8% of patients had hyperkalemia as compared to 2.2% of patients in the placebo group; levels recovered after the administration period.
About Diabetic Nephropathy in
Diabetic nephropathy is one of the most significant long-term complications in terms of morbidity and mortality for individual patients with diabetes. In
Multifactorial intensive therapy, including control of blood glucose, lipid, and blood pressure and using ARB or ACE inhibitor are recommended in the several treatment guidelines for suppressing the onset and progression of early diabetic nephropathy.3,4,5 However, these traditional therapies are suboptimal and there is a clear, unmet need for additional treatments.6
The progression to advanced stages of diabetic nephropathy is associated with increased risk of dialysis and cardiovascular events. The effect of medication on the suppression of diabetic nephropathy at the advanced stage is not clear. In order to diminish the deterioration of kidney function, it would be desirable to promote remission to normoalbuminuria in diabetic nephropathy in early stages of the disease.7, 8
About Esaxerenone in Diabetic Nephropathy
Esaxerenone is an orally administered, non-steroidal, selective blocker of MR. As recently reported, aldosterone is regarded as a potent mediator of organ damage. Esaxerenone may have a role in preventing these organ damaging effects.
Founded in 1994,
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ eligibility for substantial commercialization milestones as well as low double-digit royalties on the sale of MINNEBRO; the potential for further progress in MINNEBRO’s clinical development and commercialization; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at referenced times; risks and uncertainties related regulatory review and approval processes and Daiichi Sankyo’s compliance with applicable legal and regulatory requirements; uncertainties inherent in the product development process; the degree of market acceptance of MINNEBRO in the territories where it is approved, and Daiichi Sankyo’s ability to obtain or maintain coverage and reimbursement for this product; Exelixis’ dependence on its relationship with
Definitions of Terms
* Incipient diabetic nephropathy means type 2 diabetes with microalbuminuria, 45≦UACR＜300 mg/g Cr 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 <30 mg/g Cr (normoalbuminuria) values at the end of treatment, and 30% reduction of UACR from baseline.
‡ Overt diabetic nephropathy is defined as type 2 diabetes with UACR which is increased to equal or more than 300 mg/g Cr
1 Parving HH, et al., Prevalence and risk factors for microalbuminuria in a referred cohort of type II diabetic patients: a global perspective. Kidney Int 69:2057-2063, 2006.
2 Nitta K, et al., An overview of regular dialysis treatment in
6 Shirakami S. Drug development for unmet medical needs. OPIR Views and Actions 2015;45:30-3.
7 Gaede P, Tarnow L, Vedel P, et al., Remission to normoalbuminuria during multifactorial treatment preserves kidney function in patients with type 2 diabetes and microalbuminuria. Nephrol Dial Transplant. 2004 Nov; 19 (11):2784-8.
8 Ruggeneniti P, Fassi A, Ilieva AP, et al., Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial. J Hypertens. 2011 Feb;29 (2):207–16.
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For Exelixis, Inc.