Key Highlights

  • Independent researchers analysed 261 FSGS patients from the NEPTUNE cohort and linked CCR2 activation to worsening kidney function.
  • Higher urinary MCP-1 was associated with poorer outcomes, in line with Phase 2 data where DMX-200 reduced MCP-1 versus placebo.
  • A provisional patent application, number 2026904579, has been filed covering the new findings.
  • The ACTION3 Phase 3 adult cohort is fully recruited with 333 patients randomised across 219 sites in 21 countries.

Dimerix Limited (ASX:DXB), a clinical-stage biopharmaceutical company developing kidney disease treatments, announced on 23 October 2026 that new translational research presented at Kidney Week 2026 in Denver supports the biological rationale for its Phase 3 candidate DMX-200 in focal segmental glomerulosclerosis (FSGS). The data were presented on 22 October by Dr Sean Eddy of the University of Michigan.

What the NEPTUNE Analysis Found

The study drew on 261 FSGS patients in the Nephrotic Syndrome Study Network (NEPTUNE), a North American research cohort. It tested whether CCR2 activation is linked to biomarkers associated with kidney outcomes. The presentation was funded by Dimerix.

Researchers found CCR2 activity, an indicator of inflammation, was elevated in kidney samples from FSGS patients compared with healthy controls. Higher activity was associated with worsening kidney function, and the presentation reported a correlation of R=-0.5 between the CCR2 transcriptional activity score and eGFR. Elevated urinary MCP-1, the signalling molecule that activates CCR2, was associated with poorer clinical outcomes, including a composite endpoint of 40% loss of eGFR or end-stage kidney disease.

The authors concluded that CCR2 is a biologically relevant therapeutic target in FSGS. The findings are the subject of a newly filed provisional patent application.

Why This Could Matter

The company said the results are consistent with its Phase 2 trial, in which DMX-200 reduced MCP-1 levels while placebo-treated patients showed increases. It described the independent data and its own biomarker results as converging evidence that DMX-200 targets a pathway associated with disease progression.

Dimerix said the findings may also provide supportive biological evidence for potential regulatory filings, subject to positive outcomes from the ACTION3 Phase 3 trial. Chief Executive Dr Nina Webster said the data further strengthen the scientific rationale for targeting CCR2 as the company continues progressing the study.

The ACTION3 Study and Pipeline

ACTION3 is a multi-centre, randomised, double-blind, placebo-controlled Phase 3 study of DMX-200 in FSGS patients receiving a stable dose of an angiotensin II receptor blocker. The adult cohort is fully recruited, with 333 patients randomised across 219 sites in 21 countries. The final adult patient began treatment in March 2026 and is expected to complete dosing in March 2028, while recruitment of paediatric patients aged 12 to 17 continues as an independent cohort.

Dimerix has also acquired DMX-652, a USP30 inhibitor, which is advancing into a Phase 2 program in acute kidney injury.

Final Takeaways

The Kidney Week presentation adds independent human data on CCR2 pathway activity in FSGS to the company's existing Phase 2 biomarker results. Dimerix has lodged a provisional patent application on the findings, and the adult ACTION3 cohort is now in treatment and follow-up.