US FDA gives green light to Dimerix’s crucial Phase 3 ACTION trial
Health & Biotech
Health & Biotech
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Dimerix has achieved crucial US FDA approval as it works to give hope in the treatment of a rare kidney disease.
Aussie clinical stage biotech Dimerix (ASX:DXB) has announced its received approval from the US Food and Drug Administration (FDA) to proceed with the Phase 3 study of DMX-200 in patients with rare kidney disease focal segmental glomerulosclerosis (FSGS) in the US.
Dimerix said investigational New Drug (IND) application for its Phase 3 study is now active, paving the way for patient recruitment in the US.
The study is called “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis” – or ACTION3 for short.
ACTION3 will recruit across 75 sites in 12 different countries globally, with 19 of those clinical sites having been selected in the US.
Ethics and regulatory submissions have been made in all 12 countries, with all activated sites now proactively screening for suitable patients.
FSGS is a rare disease that attacks the kidney’s filtering units, where blood is cleaned (called the ‘glomeruli’), causing irreversible scarring.
This leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation.
The average time from a diagnosis of FSGS to the onset of complete kidney failure is only five years and it affects both adults and children as young as two years old.
For those who are fortunate enough to receive a kidney transplant, approximately 40% will get recurrent FSGS in the transplanted kidney.
Around 210,000 people worldwide suffer from FSGS each year, with 80,000 of those in the US alone.
With no existing treatment, FSGS is a billion-dollar-plus market for medical companies that can formulate innovative treatment solutions.
ACTION3 has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the study, aimed at generating sufficient evidence to support accelerated marketing approval.
The multi-centre, randomised, double-blind, placebo-controlled study aims to evaluate the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomised to receive either DMX-200 (120 mg capsule twice daily) or a placebo.
Part 1 of the study will conclude after the first interim analysis, once 72 patients have completed 35 weeks treatment, and is expected to occur in the first half of 2023 (subject to recruitment).
The study will continue seamlessly into Part 2. Patients recruited into the study will need to demonstrate a minimum of six weeks’ stable dosing of an angiotensin receptor blocker before randomisation and dosing with DMX-200 or placebo.
Dimerix CEO and managing director Dr Nina Webster said the FDA approval for ACTION3 was an important achievement for the company.
“FDA approval of our IND for the Phase 3 FSGS study is an important milestone, as it includes regulatory review of all manufacturing, nonclinical and clinical data that we have generated for the DMX-200 program to date,” Webster said.
“We are delighted to be in a position to recruit patents as we strive towards finding new and much needed treatments for patients with FSGS”.
It is also assessing the next study design in diabetic kidney disease patients.
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.