Dimerix Limited has completed recruitment for its pivotal ACTION3 Phase 3 trial targeting a rare kidney disease, secured positive FDA feedback on trial endpoints, and reported a solid cash position of AU$38.5 million at the end of 2025.
- ACTION3 Phase 3 trial recruitment of 286 adult patients completed
- FDA endorses proteinuria endpoints for marketing approval pathway
- Successful PARASOL collaboration data analysis supports trial design
- Cash position of AU$38.5 million with AU$11.1 million net operating outflows
- Ongoing pediatric cohort recruitment and open-label extension study
Clinical Milestone Achieved
Dimerix Limited (ASX – DXB), a clinical-stage biopharmaceutical company focused on kidney diseases, has reached a significant milestone by completing recruitment of 286 adult patients for its ACTION3 Phase 3 trial. This trial evaluates DMX-200, a novel treatment for focal segmental glomerulosclerosis (FSGS), a rare and serious kidney disorder characterised by progressive scarring and proteinuria.
The trial spans 219 sites across 21 countries, including major markets such as the US, Europe, and Asia-Pacific, reflecting the global ambition for DMX-200. Patients undergo a stabilisation phase on standard blood pressure medication before randomisation, ensuring rigorous trial integrity.
Regulatory Confidence and Data Validation
Dimerix has received encouraging feedback from the US Food and Drug Administration (FDA), which reaffirmed that the primary endpoint, percentage reduction in proteinuria compared to placebo, is appropriate to support traditional marketing approval. The FDA also confirmed the secondary endpoint of kidney function decline (eGFR slope) as relevant, while requesting additional documentation to maintain trial integrity before proceeding with blinded statistical analysis.
Complementing this, the company announced successful data analysis from the PARASOL collaboration, which examined observational data from major renal registries. This analysis bolsters the rationale for using proteinuria endpoints at 104 weeks and explores their relationship with long-term kidney failure risk, potentially supporting accelerated approval pathways.
Financial Position and Operational Outlook
Despite net operating cash outflows of AU$11.1 million during the December quarter, Dimerix ended 2025 with a robust cash balance of AU$38.5 million. This liquidity position is deemed sufficient to fund ongoing clinical activities, including the ACTION3 trial and exploratory R&D pipeline projects. The company notes that clinical trial expenditures are unevenly distributed, with some periods incurring higher costs aligned with milestone achievements.
Additionally, Dimerix maintains an open-label extension (OLE) study, allowing approximately 95% of patients who completed the ACTION3 trial to continue receiving DMX-200 for an additional two years. This extension not only provides continued patient access but also generates valuable long-term safety and efficacy data.
Strategic Partnerships and Future Prospects
Dimerix benefits from partnerships across multiple territories, with potential upfront and milestone payments collectively valued at around AU$1.4 billion, alongside royalties on net sales. The company continues to seek licensing opportunities in regions not yet covered by existing agreements, aiming to maximise the commercial reach of DMX-200.
Recruitment of a paediatric cohort within the ACTION3 trial is ongoing, which, if successful, could expand DMX-200’s indication to adolescents, further broadening its market potential.
Bottom Line?
With Phase 3 recruitment complete and regulatory feedback positive, Dimerix is poised for critical next steps that could define its commercial trajectory.
Questions in the middle?
- When will the FDA complete its blinded statistical powering analysis and what impact will it have on trial timelines?
- How will the ongoing paediatric cohort recruitment influence the overall market opportunity for DMX-200?
- What new licensing deals or partnerships might Dimerix announce in unlicensed territories?