Recruitment Progress Key as Dimerix Nears Completion of Rare Kidney Disease Trial
Dimerix has reached a key milestone by dosing 200 adult patients in its Phase 3 ACTION3 trial for FSGS, progressing steadily toward full recruitment expected in late 2025.
- 200 of 286 adult patients dosed, representing 70% trial completion
- Recruitment on track to finish in second half of 2025
- Trial spans over 190 sites across 22 countries
- Six safety reviews passed by Independent Data Monitoring Committee
- 43 patients entered Open Label Extension study
Clinical Trial Progress
Dimerix Limited (ASX, DXB), a clinical-stage biopharmaceutical company focused on inflammatory kidney diseases, has announced a significant recruitment milestone in its pivotal Phase 3 ACTION3 clinical trial for focal segmental glomerulosclerosis (FSGS). The company has now dosed 200 adult patients, representing approximately 70% of the total adult cohort targeted for the study.
The ACTION3 trial is a global effort, with over 190 clinical sites activated across 22 countries. This broad geographic footprint underscores the international urgency to find effective treatments for FSGS, a rare and serious kidney disorder characterized by progressive scarring and loss of kidney function. Recruitment remains on track to complete dosing of all 286 adult patients by the second half of 2025.
Safety and Extension Study
Importantly, the trial has successfully passed six safety reviews conducted by an Independent Data Monitoring Committee, providing reassurance about the tolerability of Dimerix’s investigational drug, DMX-200. Additionally, 43 patients have completed the full two-year treatment period and have transitioned into an Open Label Extension study, allowing continued access to the therapy and further data collection on long-term effects.
Therapeutic Potential and Market Outlook
DMX-200 is designed as an adjunct therapy targeting chemokine receptor 2 (CCR2) alongside standard angiotensin II receptor blocker treatment. It aims to address the inflammatory component of FSGS, a disease with no currently approved therapies worldwide. The drug benefits from orphan drug designations in both the US and Europe, which could facilitate expedited regulatory pathways and market exclusivity if approved.
CEO Dr Nina Webster highlighted the dedication of clinical teams and patients, emphasizing the trial’s progress as a critical step toward potentially transformative treatment options for those affected by FSGS. The company is also exploring licensing opportunities in territories not yet covered, signaling a strategic approach to global market access.
Looking Ahead
As recruitment nears completion, the next phases will focus on data analysis to evaluate DMX-200’s efficacy in reducing proteinuria and preserving kidney function. Positive results could pave the way for regulatory submissions and eventual approval, addressing a significant unmet medical need in nephrology.
Bottom Line?
With recruitment momentum building, Dimerix is poised to deliver critical data that could reshape treatment for a rare kidney disease.
Questions in the middle?
- When can investors expect interim efficacy data from the ACTION3 trial?
- How might recruitment challenges in pediatric patients affect overall timelines?
- What are the prospects for licensing deals in unlicensed territories?
