Abstract: INFO11-TH
ACTION3: A Phase 3 Study of DMX-200 for the Treatment of FSGS
Session Information
- Informational Posters - 1
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Fuller, David E., Dimerix Bioscience, Fitzroy, Victoria, Australia
- White, Carl, Dimerix Bioscience, Fitzroy, Victoria, Australia
Description
FSGS is a glomerular disease affecting both adults and children that can rapidly progress to end-stage kidney disease. FSGS is an area of high unmet need with no approved therapies available.
DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that when administered with an angiotensin II receptor blocker (ARB) inhibits CCR2/AT1R complex function. DMX-200 modulates the aberrant response to inflammation and reduces proteinuria, blocks attraction of inflammatory cells into the kidneys, lowers urinary MCP-1 levels, and reduces podocyte loss. A Phase 2a study (NCT03649152) in n=8 patients with FSGS found the combination of DMX-200 and irbesartan was well tolerated with most patients experiencing reductions in proteinuria and declines in the urinary biomarker MCP-1. Subsequently a Phase 3 study was initiated.
ACTION3 (NCT05183646) is a pivotal, multicentre study evaluating the efficacy and safety of DMX-200 120 mg twice daily compared with placebo in adult patients with FSGS receiving maximal tolerated ARB, with persistent proteinuria >1.5g/ day and eGFR >25ml/min/1.73m2. Primary objectives are to evaluate the efficacy of DMX-200 using percent change in 24-hour urine PCR and eGFR slope.
The study passed a futility analysis in March 2024. As of June 2025, n=207 patients were randomised with mean exposure to DMX-200 (or placebo) being approximately 52 weeks. Over this period the average patient experienced 3-4 mild to moderate adverse events. Greater than 90% of patients completing the double-blind period have enrolled in the open label extension study as of June 2025. Six Independent Data Monitoring Committee reviews have now been completed with DMX-200 (in combination with an ARB) continuing to be well tolerated with no clinically significant safety concerns identified to date.
The study is actively recruiting adult patients at 219 sites in 21 countries (Table 1) with sites open to paediatric recruitment in the UK, USA, Mexico and Argentina.
Funding
- Dimerix Ltd