Dimerix finds stronger biological case for DMX-200 in FSGS

NEPTUNE data strengthens the CCR2 case

Dimerix Limited (ASX:DXB) has added independent human data to the case for its lead kidney drug, with research presented at Kidney Week 2026 linking activation of the MCP-1/CCR2 inflammatory pathway to worsening outcomes in patients with focal segmental glomerulosclerosis, or FSGS.

The study used data from 261 FSGS patients in the internationally recognised NEPTUNE research network. Researchers found that a transcriptional activity profile associated with CCR2 was elevated in kidney tissue from FSGS patients compared with healthy living-donor controls, and that higher activity was negatively correlated with estimated glomerular filtration rate, a measure of kidney function. Similar associations were observed in both tubulointerstitial and glomerular kidney compartments.

The work was presented by Dr Sean Eddy of the University of Michigan. It included RNA sequencing data from 118 patients and single-nucleus RNA sequencing data from 33 patients, alongside clinical and urinary biomarker measures. The research was funded by Dimerix, a relevant qualification when assessing the independence of the findings, although the analysis was conducted using the NEPTUNE cohort.

Urinary MCP-1 tracked a kidney-risk signal

The study also examined whether urinary MCP-1, also known as CCL2, could act as a non-invasive indicator of CCR2 activity in the kidney. Patients with higher urinary MCP-1 relative to creatinine were associated with poorer outcomes on a composite endpoint comprising a 40% loss of eGFR or end-stage kidney disease; the reported survival comparison had a log-rank p-value of 0.04.

That result is consistent with Dimerix’s earlier Phase 2 biomarker observation that DMX-200 reduced MCP-1 levels while levels increased among placebo-treated patients. The company has now filed a provisional patent application covering the new findings and says the data may support potential regulatory submissions, subject to a positive outcome in its pivotal trial.

ACTION3 remains the clinical test

The biological evidence arrives as Dimerix’s ACTION3 Phase 3 program moves through treatment and follow-up. The adult cohort is fully recruited, with 333 patients randomised and dosed across 219 sites in 21 countries. The final adult patient began treatment in March 2026 and is expected to complete dosing in March 2028. Dimerix previously reported that ACTION3 Phase 3 funding was supported by an initial A$17 million drawdown from a non-dilutive facility.

ACTION3 is designed to assess DMX-200 at 120 milligrams twice daily against placebo in patients receiving a stable angiotensin II receptor blocker, with proteinuria and eGFR slope among the measures intended to support a potential marketing application. The new NEPTUNE analysis helps explain why CCR2 inhibition might matter in FSGS, but it remains associative translational research rather than evidence that DMX-200 improves clinical outcomes. The trial result, not the pathway narrative, will determine whether the mechanism translates into a treatment benefit.