Dimerix enters deal to advance trial into treatment for diabetic kidney disease

Dimerix will work with a key Australian diabetic organisation to start a trial on patients with diabetic kidney disease, in which there are currently no effective treatments.

Aussie clinical stage biotech Dimerix (ASX:DXB) has entered into an agreement with The Australian Centre for Accelerating Diabetes Innovations (ACADI).

The key agreement will progress its lead drug asset DMX-200 into a new clinical trial in patients with diabetic kidney disease.

The new trial provides another potential market opportunity for Dimerix in addition to its other Phase 3 trials into inflammatory diseases which are underway.

ACADI was established in January through Medical Research Future Fund (MRFF) funding from the Australian Government’s Targeted Translation Research Accelerator program, delivered by MTPConnect.

ACADI aims to accelerate innovations to improve the lives of people with or at risk of diabetic kidney disease.

The Centre was awarded $10 million over four years from the MRFF, in addition to $13.3 million in cash and in-kind contributions from 70 partners Australia-wide.

Improving outcomes in diabetic kidney disease is one of three ACADI priority areas.

High need for effective treatments

There were 23 million diagnosed diabetics in the US in 2017 and the incidence of diabetes is estimated to grow by 54% by the year 2040, due to an aging population, obesity and increasing diabetes prevalence in younger age groups.

Prevalence of obesity has nearly tripled between 1975 and 2020. In 2020, 39% of the global population was overweight, with ~30% of these clinically obese.

If the number of obese cases continue at this pace, by 2030, half of the global adult population would be overweight or obese.

The global diabetic nephropathy market size was valued at US$2.49 billion in 2021 and is estimated to rise to US$3.34 billion by 2028.

A third of people with diabetes develop diabetic kidney disease, the leading cause of end-stage kidney disease (ESKD) requiring dialysis or kidney transplant and a major risk factor for cardiovascular disease and premature death.

There is no cure for diabetic kidney disease and current treatment options are ineffective, as kidneys deteriorate towards failure.

The current treatment options include medications to reduce high blood pressure or glucose content in the blood, dialysis or kidney transplant.

The progressive nature of kidney disease inevitably results in poor outlook for patients, as it most often results in total kidney failure and a poor quality of life.

Positive data for DMX-200

Encouraging data seen in Dimerix Phase 2 study (2020) suggests greater albuminuria reductions may be observed over a longer study treatment duration.

Albuminuria is a sign of kidney disease and means there is too much albumin, a protein found in blood, in the urine. A healthy kidney doesn’t let albumin pass from the blood to the kidney.

Clinical trial protocol is being finalised and expected to be a 12-24 months study of proteinuria and eGFR (kidney function), with an interim analysis. The trial is expected to start in Q4 2022.

ACADI is led by Associate Professor Elif Ekinci from the University of Melbourne, who was also an investigator on the DMX-200 Phase 2 study completed in 2020.

Ekinci said diabetes is the key cause of kidney disease leading to dialysis and need for transplantation.

“Unfortunately, diabetic kidney disease is one of the most difficult complications of diabetes to treat and comes at a massive cost to the person living with diabetes and to our health care systems,” she said.

“We are delighted to be partnering with Dimerix to find new and potentially more effective treatments for people living with diabetic kidney disease.”

She said ACADI was pleased to see innovative therapies being researched and developed in an area of unmet need.

In further good news for Dimerix, the biotech recently completed a significant milestone in its ACTION3 Phase 3 pivotal clinical trial, following the recruitment of the first patient.

This ACTION 3 Phase 3 study is a pivotal clinical trial of DMX-200, for the treatment of focal segmental glomerulosclerosis (FSGS) disease, a rare type of kidney disease.

This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.