Dimerix (ASX:DXB) has taken another step forward in its pivotal ACTION3 Phase 3 trial for focal segmental glomerulosclerosis (FSGS), announcing that the study’s seventh scheduled Independent Data Monitoring Committee (IDMC) review has been completed with no safety concerns raised.
The committee has recommended the trial continue unchanged, reinforcing the emerging safety profile of the company’s lead asset, DMX-200.
The IDMC conducts regular, prespecified evaluations in accordance with international good clinical practice. Its latest review again confirmed that DMX-200 remains well-tolerated, consistent with all previous assessments. As of 18 November, the ACTION3 study had randomised or dosed 271 patients, including three paediatric participants.
Dimerix chief medical officer Dr David Fuller said the committee’s recommendation highlights the therapy’s potential to shift safety expectations in FSGS, a rare kidney disease with limited treatment options. “The IDMC’s recommendation underscores the strong and emerging safety profile of DMX-200,” he said. “This positions DMX-200 as a potential compelling asset in the FSGS treatment landscape, offering meaningful hope to patients with limited options and representing a significant commercial opportunity in an underserved market.”
ACTION3 is a multicentre, randomised, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of DMX-200 in patients with FSGS who remain on a stable dose of angiotensin II receptor blockers. The single global trial includes two interim analyses to assess reductions in proteinuria and changes in kidney function, generating the evidence required for regulatory approval in major markets.
The next IDMC meeting is scheduled for the second quarter of 2026, with patient recruitment and dosing continuing across international trial sites.