PERTH, Australia – With 1 in 3 patients with type 2 diabetes likely to develop diabetic kidney disease (DKD), Perth-based Proteomics International Laboratories Ltd. has developed a blood-based diagnostic test that can predict the onset of DKD, enabling patients to get treatment sooner to prevent the onset of the disease.

The CE marked PromarkerD immunoassay kit looks for protein biomarkers in the blood to detect patients at risk of clinically significant kidney decline up to four years in advance, Proteomics CEO Richard Lipscombe told BioWorld.

“You can slow the progression or stop the progression, but you can never recover,” he said, noting that kidney function can drop to 15% to 20% of normal function, and patients may not even know they have DKD. Left unchecked, those patients will need dialysis or a kidney transplant.

The ability to correctly predict an early decline in kidney function would allow doctors and patients to take action to prevent patients going on to costly dialysis or eventually facing the prospect of kidney transplant.

“If patients know they’re on the path to diabetic kidney disease, they can intervene sooner to treat the condition. A well-managed diabetic patient doesn’t get some of the more serious complications if patients can be managed early on.”

The PromarkerD is the first proteomics-derived prognostic test for DKD. There are currently no available tests for predicting the onset of DKD.

The test measures protein markers in the blood, and then factors in clinical variables such as the patient’s age, cholesterol and existing diabetic kidney disease score using the standard glomerular filtration rate (GFR) test. That data gets sent to a hub and algorithm that sends a report back to the lab.

Global study results validate the technology

A global multicenter study of 3,000 people confirmed the effectiveness of the PromarkerD predictive test. Conducted with Janssen Research & Development LLC, the retrospective study applied the PromarkerD test to patient samples from the completed phase III Canagliflozin Cardiovascular Assessment Study (CANVAS).

The retrospective analysis of blood samples from the completed trial showed that patients predicted by PromarkerD to be at high-risk of chronic kidney disease were 13.5 times more likely than the low-risk group to develop the disease.

The data confirmed previous findings that PromarkerD is able to correctly predict a clinically significant decline in kidney function up to four years in advance. Previous studies showed that the diagnostic predicted 86% of otherwise healthy diabetes patients who went on to develop CKD.

Lipscombe said the results were far-reaching for the commercial roll-out of the test because they substantiated the effectiveness of PromarkerD as a prognostic test for DKD in a globally recognized clinical cohort.

“These results show that PromarkerD works, it’s safe, and it can be run by accredited laboratories now as a laboratory developed test [LDT],” he said. “This is really a green light for using this simple blood test globally.”

The test could also save health care systems billions of dollars by identifying at-risk individuals for earlier intervention. Diabetes is the largest cause of kidney disease, and roughly 35% of adults with diabetes in the U.S. have chronic kidney disease.

The International Diabetes Federation estimates there are 463 million adults living with diabetes globally, with the annual cost of DKD estimated at $50 billion per year in the U.S. alone.

Competitive space

There are existing diagnostic tests that have been around for 50 years or so that test urine to check for albumin, which detects kidney damage. A blood test for glomerular filtration rate can also show how well the kidneys are filtering the blood. However, the two tests often conflict with each other, and they’re not able to predict future kidney disease.

Another test is being developed in the U.S. by Renalytix AI, which “targets people at the late-stage of the disease, and our test is targeting people very early,” Lipscombe said.

“The focus is on predictive diagnostics and using innovative technology to come up with new diagnostic tests,” Lipscombe said. “The business model we have is different than normal biotechs because we do have specialist analytical services that generate some revenue for us.”

“In the beginning, our objective was to find new and interesting molecules that could change the world, and here in Western Australia, we have a lot of flora and fauna that contain interesting peptides and proteins that could be bioactive. That interest led to working with hospital groups to apply the same approach to look for proteins that matter in a patient.”

“Over the years, we built a platform that could take a biological sample and extract the proteins and compare samples. The principle of looking for a fingerprint is there,” he said.

The test itself has been several years in the making. It started with a collaborative study with the University of Western Australia and the Fremantle Diabetes study, which provided the initial data. The company also worked with the Busselton Health Study, another major epidemiological study in Western Australia.

“Both of those studies were key to us getting the right patients together so we could ask the question, ‘What is going on and why do some people get diabetic kidney disease and others don’t?’”

The R&D side is very much the focus today, and the company is exploring other indications using the Promarker technology platform to create a pipeline of diagnostic tests. Indications in development include endometriosis and giardia, as well as research into a COVID-19 diagnostic and biomarker

The company has staff in India and the U.S. and a director in Japan, “so we’re well positioned to take the test to those markets,” he said.

Proteomics is looking to partner with big pharma or diagnostics companies. The company presented data at the American Diabetes Association earlier this summer, and it expanded its partnership with Janssen earlier this year.

The PromarkerD could potentially be used as a complementary diagnostic for pharma companies developing drugs in the kidney disease space. The test also has application as a diagnostic for pharma companies to identify potential responders for their therapies.

Proteomics is also exploring with Melbourne-based Dimerix Ltd. how PromarkerD might align with its kidney disease therapy DMX-200 in development.

“The objective for both companies is that they want to understand the progression of the disease, and if they want to come up with a marker that indicates who is at risk, then obviously that becomes a person you would want to treat sooner than someone who is not at risk.”

Lipscombe co-founded Proteomics in 2001, and it listed on the Australian Securities Exchange (ASX:PIQ) in 2015. The company was self-funded from the start, he said, and Commercialization Australia gave Proteomics an AU$1 million (US$725,409) grant in 2012 to develop its biomarkers for diabetic kidney disease.

With a market cap of roughly AU$60 million, Proteomics shares are trading at AU65 cents per share.

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