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.