Dimerix shares up 8% on DMX-200 FSGS Phase 3 trial news
Health & Biotech
Health & Biotech
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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.
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.
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.”
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.