Dimerix hits key milestone in Europe with first regulatory approval for its Phase 3 FSGS study, shares jump

This is the first time DMX-200 has been approved for use in kidney patients by a regulator outside of Australia and New Zealand.

After receiving its first regulatory approval in Europe, Dimerix (ASX:DXB) says it will now focus on recruitment, starting with Australia where it already has ethics approval, whilst continuing to roll out the study globally.

The company confirmed another key milestone today with news that the Danish Medicines Agency has issued regulatory approval for the ACTION3 Phase 3 study in Denmark.

Investors responded to announcement, sending DXB shares more than 10% higher in afternoon trade on Tuesday.

Dimerix’s pivotal phase-3 clinical trial, ACTION3 will evaluate the efficacy and safety of DMX-200 against a placebo in patients with Focal Segmental Glomerulosclerosis (FSGS) kidney disease who are receiving a stable dose of an angiotensin II receptor blocker (ARB).

Once the ARB dose is stable, patients, aged 18 to 80 years, will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.

What is FSGS?

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 re-occurring FSGS in the transplanted kidney.

At this time, there are no drugs specifically approved for FSGS anywhere in the world.

In that context, Dimerix has already received an Orphan Drug Designation from regulators in the US, Europe and the UK, which supports the pathway for accelerated (or fast tracked) approval of the DMX-200 treatment, in the event of successful trial results

Global sites selected to conduct trial

The trial has two interim analysis points built in that are designed to capture evidence of both proteinuria and kidney function (eGFR slope) during the study, aimed at generating sufficient evidence to support accelerated marketing approval.

Dimerix has selected 73 of the planned 75 global sites (97%) across 12 countries to conduct part 1 of the Phase 3 study (first interim analysis point), and 15 of those 75 sites are in Europe.

Clinical studies in respiratory complications associated with COVID-19

Elsewhere, Dimerix also flagged ongoing developments two other global phase-3 clinical studies, on the use of DMX-200 to treat respiratory complications associated with COVID-19.

The company highlighted that it proactively supports both studies driven by the REMAP-CAP and CLARITY 2.0 teams, in providing them information for the regulatory submissions and in supplying DMX-200 to the study sites.

Patient dosing in India for the CLARITY 2.0 study has now commenced, with results from the interim safety analysis expected before the end of the March quarter.

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.