Dimerix takes major step in global Phase 3 FSGS trial with key ethics and regulatory approval in Australia

Ethics submissions for DXB’s Phase 3 trial in other key jurisdictions is expected before the end of the year.

Clinical stage biopharmaceutical company Dimerix (ASX:DXB) is fully-funded and ready to commence the Phase 3 clinical study of its lead drug candidate, DMX-200, for patients with FSGS (Focal Segmental Glomerulosclerosis) – a rare kidney disease.

And the company announced its latest step forward this morning, with confirmation it has received Australian ethics and regulatory approval for the trial, named ACTION3.

It marks the first ethics and regulatory approval for ACTION 3, a global trial that is expected to take place in around 75 jurisdictions globally, Dimerix said.

Commenting on the update, Dimerix CEO Nina Webster said ethics and regulatory approval in Australia marks a “significant milestone for the company”.

“We expect recruitment to begin this quarter and look forward to reporting on recruitment progress and our first interim analysis in due course,” Webster said.

Next steps

Of the 75 sites globally, Dimerix said it has now selected around more than half of them to conduct Part 1 of the study – the first interim analysis point. Five of the sites will be in Australia.

The study has been structured to evaluate two interim analysis points, “designed to capture evidence of both proteinuria and kidney function (eGFR slope)”, Dimerix said.

The company is aiming for successful results on those interim analysis points, which could in turn provide the basis for regulators to grant the treatment with accelerated marketing approval (a quicker path to market).

Dimerix has already received an Orphan Drug Designation from regulators in the US, Europe and the UK, which supports the pathway for accelerated approval of the DMX-200 treatment, in the event of successful trial results.

In that context, ethics and regulatory approval in an advanced medical market such as Australia marks another important step forward.

Ethics approval “is a fairly extensive process, and typically takes 6-8 weeks to complete,” Webster told Stockhead recently.

“So Australia went first, and we are rolling out the program country-by-country.”

Ethics submissions in other key jurisdictions, including the US and Europe, “are anticipated in the quarter ending December 2021”, Dimerix said.

With global momentum continuing to build around its trial process, Dimerix is working towards a new solution to treat FSGS – a rare disease which causes irreversible kidney scarring.

Around 210,000 people worldwide suffer from the disease 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.

Dimerix continues to develop its Phase 3 FSGS trials as part of a multi-channel development pathway, which includes its DMX-700 COPD program for diabetic kidney disease, and the application of DMX-200 in two global Phase 3 studies for COVID-19 patients with respiratory complications.

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.