Key Highlights

  • Dimerix announced on 23 October 2026 that new CCR2 and urinary biomarker data in FSGS were presented on 22 October at Kidney Week 2026 in Denver.
  • The analysis used NEPTUNE data from 261 patients, and the company reported a CCR2 activity correlation with eGFR of R equal to minus 0.5.
  • The ACTION3 Phase 3 trial has randomised and dosed 333 adults, with the last adult expected to complete dosing in March 2028.

Dimerix (ASX:DXB) announced on 23 October 2026 (Sydney time) that new data supporting the biological rationale for DMX-200 in focal segmental glomerulosclerosis (FSGS) had been presented on 22 October at Kidney Week 2026 in Denver. The presentation was given by Dr Sean Eddy of the University of Michigan and was titled as an analysis of intrarenal CCL2 and CCR2 activation profiles and their link to non-invasive urinary biomarkers associated with outcomes in patients with FSGS. Dimerix said the study was funded by the company, and the release describes the researchers as independent.

The analysis used data from NEPTUNE, the Nephrotic Syndrome Study Network, which spans 32 North American sites and enrolled 261 patients. Kidney tissue was available for subsets of the cohort, with 118 patients having bulk RNA sequencing and 33 having single-nucleus RNA sequencing. Baseline characteristics included a mean age of 34, an average eGFR of 70 and a median urine protein-to-creatinine ratio of 3.6 mg/mg, with 22 per cent of patients at high risk of APOL1-related disease.

According to the release, CCR2 transcriptional activity was elevated in FSGS compared with healthy controls and showed a negative correlation with eGFR, with a reported correlation of R equal to minus 0.5 and a p-value below 0.0001. A CCR2 activity score was built from a network of 206 shared genes. Separately, urine MCP-1 normalised to creatinine was associated with a composite endpoint of a 40 per cent or greater loss of eGFR or end-stage kidney disease, with a log-rank p-value of 0.04. Dimerix also said it has filed a new provisional Patent application, number 2026904579.

The company said the work is consistent with the mechanism of DMX-200, which is to block the CCR2 receptor alongside a stable angiotensin II receptor blocker. It cited its 2020 Phase 2 results, in which DMX-200 reduced MCP-1 levels while placebo-treated patients showed increases, but stated that these are biomarker data and that clinical efficacy remains subject to the ACTION3 trial.

ACTION3 and the wider pipeline

ACTION3 is a pivotal, randomised, double-blind, placebo-controlled Phase 3 trial comparing DMX-200 at 120 mg twice daily with placebo in FSGS patients on a stable blocker dose. It has randomised and dosed 333 adults across 219 sites in 21 countries. The company said recruitment is complete, with the last adult starting treatment in March 2026 and the last adult expected to complete dosing in March 2028. The trial's endpoints are proteinuria and eGFR slope. A paediatric cohort aged 12 to 17 is recruiting separately.

Dimerix (ASX:DXB) reports Orphan Drug designation for DMX-200 in the United States, Europe, the United Kingdom and Japan, and estimates more than 40,000 people in the United States have FSGS. It also described DMX-652, a USP30 inhibitor being developed for acute kidney injury, which has an open US investigational new drug application and an FDA-approved Phase 2 protocol.

What remains uncertain

The release does not give a date for ACTION3 topline results, and potential regulatory filings are described as dependent on a positive outcome. The new analysis is associative and observational. The company described ACTION3 as a potential major value-creating event, which is its own characterisation. The only dated milestone given is the expected March 2028 completion of dosing for the last adult.