Recruitment on track for Dimerix’s global kidney disease trial

Dimerix recruits Part 2 cohort of patients for ACTION3 global phase III trial
Interim analysis data collection currently scheduled for August 2025
Full recruitment of 286 adult patients expected Q3 CY25
The company’s treatment has orphan drug designation

Special Report: Clinical-stage biotech company Dimerix has completed recruitment of part 2 of its ACTION3 global phase III trial of its lead drug DMX-200 to treat focal segmental glomerulosclerosis (FSGS).

FSGS is rare disease that attacks the kidneys and results in irreversible scarring, leading to permanent kidney damage and eventually end-stage kidney failure, requiring dialysis or transplantation.

This phase III trial is a randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).

Planned blinded interim data collection is anticipated in August 2025, following 35 weeks’ dosing of the first 144 patients.

“The randomisation of the first 144 patients into our DMX-200 ACTION3 Phase 3 FSGS kidney clinical trial is a major milestone for Dimerix,” said Dimerix (ASX:DXB) CEO and managing director Dr Nina Webster.

“This triggers the current planned blinded data collection in August 2025, after 35 weeks treatment, with the Part 2 interim analysis outcome expected to be announced shortly thereafter.

“Based on current projections we expect to complete recruitment for the full study in Q3/2025.”

Importantly, patients, physicians and Dimerix staff will remain blinded to patient allocation (i.e. which patients are receiving DMX-200 and which are receiving placebo) at all times during the study, including at the second interim analysis timepoint.

Accelerated approval could be on the cards

FSGS affects both adults and children as young as two years old and there are currently no drugs specifically approved for FSGS anywhere in the world, limiting treatment options and overall prognosis.

As such, the DMX-200 drug has secured Orphan Drug Designation in both the US and Europe, and the equivalent Innovative Licensing and Access Pathway (ILAP) designation in the UK.

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.

“Subject to ongoing guidance and correspondence with the appropriate authorities, the company may be able to apply for accelerated (or conditional) approval of DMX-200 in some key territories which could, if approved, enable commercial launch of DMX-200 prior to the completion of the two-year double blind ACTION3 Phase 3 clinical trial,” Dr Webster said.

“We know FSGS patients today face poor outcomes with limited treatment options, and upon trial success, DMX-200 could be a significant advancement in the treatment of FSGS providing hope to the FSGS community.”

The FSGS market is significant, with more than 80,000 people in the US affected and around 220,000 worldwide.

Open label extension study

Several territories around the world require compulsory access to the experimental treatment for patients as they complete a clinical trial, and following the successful part 1, Dimerix now has an open label extension (OLE) study in place to ensure data can be collected from these patients.

The OLE study will allow all patients access to DMX-200 once they have completed the ACTION3 clinical trial and follow them for a further two years – proving further study risk mitigation and long-term data.

To date, 14 patients have completed the two-year ACTION3 phase III study and have elected to continue into the OLE.

The company anticipates the OLE study is to be funded through current cash reserves as well as future licensee milestone payments under the existing partnering arrangements.

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.