Dimerix Completes Recruitment in Pivotal Phase 3 Trial for Rare Kidney Disease
Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.
- Completed recruitment and dosing of 286 adult patients in ACTION3 Phase 3 trial
- Positive interim results showing DMX-200 reduces proteinuria in FSGS patients
- 94% of eligible patients entered Open Label Extension study
- Ongoing pediatric recruitment as an independent cohort
- Plans to seek FDA feedback on trial endpoints and accelerated approval
Milestone Achieved in Rare Kidney Disease Trial
Dimerix Limited, an Australian biopharmaceutical company, has announced the successful completion of recruitment and dosing of 286 adult patients in its pivotal Phase 3 ACTION3 clinical trial. The trial evaluates DMX-200, a novel therapy targeting focal segmental glomerulosclerosis (FSGS), a rare and serious kidney disorder characterized by progressive scarring and loss of kidney function.
The ACTION3 study is a multi-centre, randomized, double-blind, placebo-controlled trial conducted across 219 sites in 21 countries, including the US, Europe, and Asia-Pacific regions. Patients enrolled are receiving standard blood pressure medication, specifically angiotensin II receptor blockers (ARBs), alongside either DMX-200 or placebo over a two-year treatment period.
Encouraging Early Data and High Patient Retention
Earlier interim analysis of the trial’s first 72 patients demonstrated promising efficacy, with DMX-200 showing a statistically significant reduction in proteinuria; a key marker of kidney disease progression; compared to placebo. This early signal has bolstered confidence in the drug’s potential to modify disease course in FSGS patients.
Of the 69 patients who have completed the full two-year treatment, an impressive 94% have opted to continue into the Open Label Extension study, underscoring strong patient engagement and perceived benefit. The trial has also passed seven independent safety reviews without any protocol changes or safety concerns, reinforcing the drug’s tolerability profile.
Next Steps and Regulatory Strategy
Dimerix, in partnership with US-based Amicus Therapeutics, plans to seek feedback from the FDA on the clinical trial endpoints ahead of the blinded data analysis. This step is critical to align on the regulatory pathway, including the possibility of accelerated approval based on the 104-week data.
Meanwhile, recruitment continues for a pediatric cohort, which, if successful, could expand DMX-200’s indication to adolescent patients; a significant opportunity given the lack of approved therapies for FSGS in younger populations.
Financial Position and Outlook
Dimerix maintains a strong cash position to support the ongoing trial and explore new research and development opportunities. CEO Dr Nina Webster highlighted the operational excellence demonstrated in executing this complex trial across multiple countries and expressed gratitude to patients and families contributing to this important program.
As the company moves toward key data readouts and regulatory discussions, the biopharmaceutical sector and investors will be watching closely for results that could transform treatment options for a disease with significant unmet medical need.
Bottom Line?
With recruitment complete and promising interim data, Dimerix is poised for critical regulatory milestones that could reshape FSGS treatment.
Questions in the middle?
- Will the final blinded analysis confirm the interim efficacy signals for DMX-200?
- How will the FDA respond to the proposed trial endpoints and accelerated approval pathway?
- What progress will be made in enrolling and demonstrating efficacy in the pediatric cohort?
