Dimerix has hit a major milestone in its bid to provide an effective treatment for patients with a rare kidney disease.

Clinical stage biopharmaceutical company Dimerix (ASX:DXB) has announced it has started the Phase 3 clinical study of its lead drug candidate DMX-200 in patients with rare kidney disease Focal Segmental Glomerulosclerosis (FSGS).

Dimerix has filed the first ethics submission in Australia for its study titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis or ACTION3 for short.

Upon approval of the submission, patients can be recruited into the final, multi-centre, randomised, double-blinded, placebo-controlled study of the efficacy and safety of Dimerix’s proprietary CCR2-inhibitor DMX-200 as a treatment for FSGS.


DMX-200 gives hope to FSGS sufferers worldwide

FSGS attacks the kidney’s filtering units where blood is cleaned causing irreversible scarring, which leads to permanent kidney damage and failure requiring dialysis or transplantation.  For sufferers who receive a kidney transplant, approximately 40% will get re-occurring FSGS in the transplanted kidney.

FSGS is a billion-dollar plus market, affecting around 210,000 people globally each year with a compound annual growth rate of 8%. There are currently no treatments approved for the treatment of FSGS with a strong unmet medical need.

For sufferers, researchers and clinicians treating FSGS, the DMX-200 Phase 3 trial provides hope an effective treatment may not be too far  away.

Dimerix  has already  received Orphan  Drug  Designation  for  DMX-200  in  both  the  US  and  Europe,  and  the equivalent Innovative Licensing and Access Pathway (ILAP) designation in the UK, for the treatment of  FSGS.

These  designations  provide  regulatory  and  financial  benefits  to  help  bring  new  drugs  to market  faster,  including  reduced  fees  during  the  product  development  phase,  protocol  assistance from  the  regulatory authorities,  and  7-year  (US)  and  10-year  (Europe)  market  exclusivity  following product approval.


Patients worldwide to take part in Phase 3 study

Up to 167 sites in 18 countries across North America, South America, Europe, United Kingdom, and  Asia  Pacific  regions  are  expected  to  participate  in  ACTION3.

Australia and  New Zealand have been identified as the first countries planned to initiate patient recruitment across five sites collectively with other countries to quickly follow.

Dimerix managing director and CEO Nina Webster said the team felt positive about the Phase 3 trials.

“We  have designed  interim  analyses  into  the  Phase  3 study design  to  capture  evidence  of proteinuria  and  kidney  function improvement during  the  study,  aimed at  generating sufficient data to support accelerated marketing approval,” Dr Webster said.

“With the key regulators’ expectations aligned, including  the  US FDA and  the  European  EMA and  encouraging  data  reported  in  the  prior Phase 2a study, we are excited to deliver on the FSGS program, potentially providing patients with a much-needed treatment option.”


DMX-200 Phase 3 trials into COVID-19 treatment continue

As the world remains in the grip of the COVID-19 pandemic, along with its FSGS study,  Dimerix’s DMX-200 is also being assessed in two global Phase 3 trials for patients who develop respiratory complications.

If DMX-200 is effective in those COVID-19 respiratory complications, it would likely be equally effective against any strain of COVID as well as other infections such as influenza and pneumonia, providing an opportunity stretching beyond the current pandemic.

Shares in Dimerix rose 8.33% to 32 cents upon news of the FSGS trial.

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.