Dimerix’s DMX-200 Clears Seventh Safety Review in Pivotal FSGS Trial

Continued Confidence in DMX-200’s Safety

Dimerix Limited, an Australian biopharmaceutical company, has announced the successful completion of the seventh Independent Data Monitoring Committee (IDMC) review for its pivotal Phase 3 ACTION3 clinical trial. This trial is evaluating DMX-200, a novel therapy targeting Focal Segmental Glomerulosclerosis (FSGS), a rare and serious kidney disease with limited treatment options.

The IDMC, responsible for overseeing patient safety and trial integrity, found no safety concerns during this latest review and recommended the trial proceed without any modifications. This consistent endorsement highlights DMX-200’s emerging strong safety profile, a critical factor given the high side-effect burden associated with current FSGS treatments such as high-dose steroids and immunosuppressants.

Trial Progress and Patient Enrollment

As of mid-November 2025, the ACTION3 trial has randomized and dosed 271 patients, including 268 adults and 3 pediatric participants. The study is a randomized, double-blind, placebo-controlled trial assessing DMX-200’s efficacy and safety in patients already stabilized on angiotensin II receptor blockers, the current standard of care for hypertension and kidney disease.

The trial design incorporates two interim analysis points focused on proteinuria and kidney function, which are key markers of disease progression and treatment effect. These analyses aim to generate robust evidence to support regulatory approval and eventual market access.

Market Potential and Next Steps

FSGS remains an underserved market with no approved therapies in the United States and a high unmet medical need. DMX-200’s mechanism as a CCR2 antagonist combined with AT1R blockade offers a differentiated approach that could improve patient outcomes while minimizing side effects.

With granted patents protecting DMX-200 until at least 2032 and orphan drug designation from the FDA, Dimerix is well positioned to capitalize on this opportunity. The next IDMC review is scheduled for the second quarter of 2026, which will provide further insights into the trial’s progress and safety data.

Overall, the continued positive safety assessments bolster confidence in DMX-200’s potential as a transformative treatment for FSGS, offering hope to patients facing a challenging prognosis and limited therapeutic options.