Highlights

• Dimerix reported human research linking CCR2 activity with poorer FSGS outcomes.

• The study assessed data from 261 patients.

• The company connected the findings with earlier DMX-200 biomarker results.

• Dimerix retained Phase 3 outcomes as the test of clinical efficacy.

Dimerix (ASX:DXB) is a clinical-stage biopharmaceutical company developing treatments for kidney diseases, led by DMX-200 for focal segmental glomerulosclerosis, or FSGS. Its program targets an inflammatory pathway associated with kidney damage rather than relying solely on supportive treatment. The 23 October 2026 update described new human research supporting that biological rationale, while leaving the medicine's clinical efficacy dependent on the ongoing ACTION3 Phase 3 study.

Human Data Connect the Target with Outcomes

The research assessed 261 patients to examine whether activation of the CCR2 pathway was associated with biomarkers and kidney outcomes in FSGS. It found significantly elevated CCR2 activity in kidney samples from patients with the disease compared with healthy controls.

Higher activity was associated with worsening kidney function. Elevated urinary MCP-1 levels were also linked to poorer clinical outcomes.

MCP-1, also called CCL2, is a signalling molecule that activates the CCR2 receptor. The pathway recruits inflammatory cells into the kidney, contributing to ongoing damage and fibrosis. The findings therefore supported the relevance of the target that DMX-200 is designed to inhibit.

Biomarker Findings Build a Connected Rationale

The new observations aligned with the company's Phase 2 biomarker results. In that study, DMX-200 reduced urinary MCP-1 levels, while levels increased among placebo-treated patients.

Together, the findings linked the proposed target to disease progression and showed a related biomarker response in the earlier treatment study. They did not establish that DMX-200 would produce a successful Phase 3 outcome.

The research was funded by Dimerix and presented on 22 October 2026. Its findings formed the subject of a newly filed provisional patent application and could support potential regulatory submissions, subject to positive ACTION3 results.

ACTION3 Moves through Treatment and Follow-up

The adult ACTION3 cohort was fully recruited, with 333 patients randomised and dosed globally. Recruitment had been completed across 219 sites in 21 countries.

The study is randomised, double-blind and placebo-controlled, testing the efficacy and safety of DMX-200 in patients receiving a stable dose of an angiotensin receptor blocker. Participants receive a 120-milligram capsule twice daily or placebo.

The final adult patient began treatment in March 2026 and was expected to complete dosing in March 2028. The trial was therefore in its treatment and follow-up phase, rather than awaiting additional adult recruitment.

An independent paediatric cohort continued to recruit patients aged 12-17 years. That work could support future expansion into adolescent indications in relevant territories.

Clinical Evidence Remains the Decisive Step

The Phase 3 design captures proteinuria and kidney-function measures, including estimated glomerular filtration rate slope, with the aim of generating evidence for marketing approval.

Biological support is one part of that development case. Demonstrating clinical benefit and safety remains a separate requirement, and the update explicitly retained that distinction.

The company was also advancing DMX-652 toward Phase 2 development in acute kidney injury, adding a second asset to its kidney-disease pipeline. For the lead program, the principal unresolved matter remained the eventual ACTION3 outcome, which would determine whether the pathway rationale translated into treatment evidence.