Diabetes treatment lowers PromarkerD risk score for diabetic kidney disease

BRISBANE,Australia,Aug. 12,2021 -- Treatment with diabetes drug canagliflozin lowers the PromarkerD risk score for developing diabetic kidney disease in patients with type 2 diabetes,latest research suggests.

In a study presented at the Australasian Diabetes Congress today,researchers used PromarkerD,the world's first predictive diagnostic test for diabetic kidney disease or "DKD",to test blood samples from more than 2,000 type 2 diabetes patients who had taken part in a clinical trial of the drug.

The study found the average PromarkerD risk score of patients taking canagliflozin,an SGLT2-inhibitor diabetes drug,reduced significantly during the three-year trial.

PromarkerD is a simple biomarker-based blood test developed by Australian medical technology company Proteomics International Laboratories Ltd (ASX:PIQ). It is the only available test capable of reliably predicting future kidney function decline in patients with type 2 diabetes and no existing DKD[*]. The PromarkerD prognostic test can predict the onset of the asymptomatic disease up to four years in advance.

Canagliflozin is an approved diabetes therapy with additional renal and cardiovascular benefits. It is the first diabetes medicine approved by the US Food and Drug Administration (FDA) to treat DKD,and shown to slow the disease progression in patients with type 2 diabetes and DKD.

The study examined the association between canagliflozin and change in PromarkerD risk scores over a three-year period in type 2 diabetes patients in the completed CANagliflozin cardioVascular Assessment Study (CANVAS). The research retrospectively measured PromarkerD risk scores for developing DKD in blood samples from 2,008 patients taken at the start of the trial and again three years later. All patients had diabetes but no existing DKD,and were randomly allocated to take either canagliflozin or a placebo.

The study found the average PromarkerD risk score in patients taking canagliflozin dropped 1% during the trial,while the average risk score of patients taking a placebo rose 4%[†]. Importantly,the greatest reductions in risk score were seen in the patients classified by PromarkerD as being at high risk of developing DKD at the start of the trial - here the PromarkerD risk score of patients taking canagliflozin dropped 6%. Each of these results was statistically significant.

Proteomics International managing director Dr Richard Lipscombe said the research further validated the power of the PromarkerD test. "Our previously published clinical studies have shown the power of PromarkerD to predict the onset of diabetic kidney disease before clinical symptoms appear," he said.

"Now,for the first time,we are confirming that this SGLT2 inhibitor class of diabetes drug can improve people's renal risk profile. It means there is a potential treatment for type 2 diabetes patients identified by PromarkerD as being at high risk of diabetic kidney disease,giving them the chance to reduce their risk of developing symptoms in the future."

The study is being presented at the Australasian Diabetes Congress in Brisbane,from 11-13 August 2021.

Australasian Diabetes Congress presentation(ID: 27; Track: ADS Clinical ePosters)

Titled: Canagliflozin attenuates PromarkerD diabetic kidney disease risk prediction scores

KE Petersa,b,K Spilsburya,J Xuc,SD Bringansa,TME Davisb,N Rosenthalc,MK Hansenc,RJ Lipscombea

a Proteomics International,Perth,WA,Australia; b Medical School,University of Western Australia,Crawley,Australia; c Janssen Research & Development,LLC,Spring House,PA,USA.

[*] No existing diabetic kidney disease (DKD) defined as estimated Glomerular Filtration Rate (eGFR) ≥60 mL/min/1.73m2

[†] ASX. PIQ 16 July 2021

About Diabetes and Diabetic Kidney Disease

Type 2 diabetes is a global health problem affecting 463 million adults worldwide [1]. Diabetes can cause serious and life-threatening complications,including diabetic kidney disease (DKD),a chronic and progressive kidney disease that if unchecked can lead to end stage renal disease (ESRD) resulting in dialysis or kidney transplant. Currently,1-in-3 adults with diabetes are estimated to have DKD [2]. Diabetes is the leading cause of kidney disease in the United States and 39% of ESRD cases are attributable to diabetes [2]. Diabetes–associated chronic kidney disease is the 16th leading cause of death in the US,accounting for 40,000 deaths per year [3]. Average treatment costs for dialysis are $72,000 per person per year,with kidney disease and ESRD costing US Medicare $130 billion annually [4]. The current gold standard diagnostic tests for DKD are the urinary albumin–to-creatinine ratio (uACR ≥30 mg/g) and reduced estimated glomerular filtration rate (eGFR <60 mL/min/1.73m2). Both these tests lack precision and sensitivity [5] and,critically,they have limited performance in predicting future decline in renal function [6].

About PromarkerD(www.PromarkerD.com)

Diabetic kidney disease (DKD) is a serious complication arising from diabetes which if unchecked can lead to dialysis or kidney transplant. PromarkerD is a prognostic test that can predict future kidney function decline in patients with type 2 diabetes and no existing DKD. The patented PromarkerD test system uses a simple blood test to detect a unique 'fingerprint' of the early onset of the disease by measuringthree serum protein biomarkers,combined with three routinely available conventional clinical variables (age,HDL-cholesterol and estimated glomerular filtration rate (eGFR)) [7]. In clinical studies published in leading journalsPromarkerD correctly predicted up to 86% of otherwise healthy diabetics who went on to develop diabetic kidney disease within four years [8,9]. The PromarkerD test is CE Mark registered in the European Union.

Further information is available through the PromarkerD web portal.

To visit the PromarkerD virtual booth please see: www.PromarkerD.com/product

[1] International Diabetes Federation Diabetes Atlas 2019.

[2] Centers for Disease Control and Prevention. Chronic Kidney Disease National Facts 2021.

[3] Mokdad AH et al. The State of US Health,1990–2016: Burden of Diseases,Injuries,and Risk Factors Among US States. JAMA 2018

[4] United States Renal Data System 2020 Annual Data Report.

[5] Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group,M. KDIGO 2012 Clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int. Suppl. 2013.

[6] Dunkler,D et al,R. Risk Prediction for Early CKD in Type 2 Diabetes. Clin. J. Am. Soc. Nephrol. 2015.

[7] Peters KE et al. Identification of Novel Circulating Biomarkers Predicting Rapid Decline in Renal Function in Type 2 Diabetes: The Fremantle Diabetes Study Phase II. Diabetes Care. 2017.

[8] Peters KE et al. Validation of a Protein Biomarker Test for Predicting Renal Decline in Type 2 Diabetes: The Fremantle Diabetes Study Phase II. J Diab Comp. 2019.

[9] Peters KE et al. PromarkerD Predicts Renal Function Decline in Type 2 Diabetes in the Canagliflozin Cardiovascular Assessment Study (CANVAS). Journal of Clinical Medicine. 2020.

About Proteomics International Laboratories (PILL) (www.proteomicsinternational.com)

Proteomics International (Perth,Western Australia) is a wholly owned subsidiary and trading name of PILL (ASX: PIQ),a medical technology company at the forefront of predictive diagnostics and bio-analytical services. The Company specialises in the area of proteomics – the industrial scale study of the structure and function of proteins.Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.

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