Business
DMX-200 ACTION3 PHASE 3 TRIAL COMPLETES RECRUITMENT
Dimerix Limited (ASX: DXB), a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, today announces that the ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) has now successfully completed the planned recruitment and dosing of the 286th adult patient[1].
About this update from Dimerix Limited
[{"type":"list","items":[{"val":[{"type":"text","content":"Recruitment successfully completed in Dimerix' ACTION3 Phase 3 clinical trial[1], which has recruited and dosed its target 286th adult patient","length":146,"tagName":"p"}]},{"val":[{"type":"text","content":"The ACTION3 Phase 3 trial explores the efficacy and safety of DMX-200 in FSGS patients when dosed in combination with standard-of-care blood pressure medication over 2 years","length":173,"tagName":"p"}]},{"val":[{"type":"text","content":"Of the 286 adult patients dosed in the trial, 69 have already completed the full 2-year treatment period and of those, 65 entered voluntarily into the Open Label Extension (OLE) study, representing 94% OLE uptake","length":212,"tagName":"p"}]},{"val":[{"type":"text","content":"The study has now successfully passed seven scheduled Independent Data Monitoring Committee (IDMC) reviews with no changes to the protocol required or safety concerns identified[2]","length":180,"tagName":"p"}]},{"val":[{"type":"text","content":"Following the successful outcome of the PARASOL collaboration data analysis (PARASOL Findings), Dimerix and its U.S. partner, Amicus Therapeutics, intend to seek feedback from the FDA on the proposed clinical trial endpoints, prior to a blinded analysis of ACTION3 data[3]","length":272,"tagName":"p"}]},{"val":[{"type":"text","content":"Recruitment of pediatric patients remains ongoing as an independent cohort in the trial, and if successful, may allow Dimerix to expand its application for DMX-200 to adolescents in key territories","length":197,"tagName":"p"}]},{"val":[{"type":"text","content":"Dimerix continues to maintain a strong cash position to fund its operations, including the ongoing ACTION3 Phase 3 clinical trial as well as assess new R&D opportunities","length":173,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":1353,"olType":false},{"type":"text","content":"MELBOURNE, Australia, Dec. 15, 2025 /PRNewswire/ -- Dimerix Limited (ASX: DXB), a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, today announces that the ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) has now successfully completed the planned recruitment and dosing of the 286th adult patient[1].","length":375,"tagName":"p"},{"type":"text","content":"The ACTION3 Phase 3 study is a piv...