Australia-based Proteomics International (PI) has developed PromarkerD, a predictive and diagnostic test for diabetic kidney disease that measures a protein biomarker panel in the blood. Dimerix has developed a candidate drug therapy for chronic kidney disease, known as DMX-200.
The DMX-200 therapeutic showed promising efficacy signals in a recent Phase 2a clinical trial, particularly in patients with diabetic kidney disease, whilst PromarkerD has been shown in clinical studies to predict rapid decline in kidney function up to four years in advance. Proteomics International and Dimerix will evaluate the performance of PromarkerD alongside DMX200 in early phase clinical trials for chronic kidney disease.
The condition is referred to as a ‘silent disease’ because it often has no symptoms in its early stages and can go undetected until it is very advanced. PromarkerD has the potential to serve as a Companion Diagnostic test (CDx) in clinical trials to help measure and monitor the effectiveness of a drug. The FDA states a CDx provides information that is essential for the safe and effective use of a corresponding drug. A CDx can help identify at risk patients who might benefit from taking the drug, enable more accurate dosing, and help monitor clinical end points and side effects. In combination, a validated CDx can improve the success rate of drug candidates.
It is expected the PromarkerD test will be used to explore the response of healthy volunteers to treatment in the Dimerix Phase 1 pharmacokinetic (PK) study currently underway at Linear Clinical Research (Perth, Australia), and in its upcoming Phase 2 trial program.
PromarkerD has been rated the world’s leading diagnostic test for diabetic kidney disease by global market research firm Frost & Sullivan. Early disease detection with PromarkerD allows early therapeutic intervention with drugs such as DMX-200 and may enable the onset of disease to be delayed or prevented altogether, with potentially dramatic savings for global healthcare systems.
In the United States 30 million people suffer from chronic kidney disease, with currently 44% of cases attributed to diabetes. Medicare spending for patients with chronic kidney disease aged 65 and older exceeded US$50 billion in 2013, and represented 20% of all Medicare spending in this age group.
If PromarkerD proves successful as a Companion Diagnostic test to support the use of DMX-200 as treatment for chronic kidney disease then Dimerix will have the option to licence PromarkerD for ongoing use. Preliminary results will be available during 2018. CEO of Dimerix, Kathy Harrison said “Chronic Kidney Disease is a massive and rapidly growing issue. Many patients are diagnosed too late and the existing treatments can have little to no effect.
Having a test which can predict disease progression will undoubtedly be beneficial to both controlling disease and treating it with new drugs like DMX-200.” Proteomics International’s Managing Director, Dr Richard Lipscombe added “It’s great to see Australian innovation leading the world in the treatment of kidney disease and diabetes. The era of precision medicine is here and we’re delighted to be working with Dimerix to try to improve the speed of drug development. This could benefit patients around the world.”