• Successful recruitment and dosing of 286 adult patients in ACTION3 Phase 3 trial of DMX-200 for FSGS
• 94% of patients who completed the 2-year trial entered the Open Label Extension study
• Trial has passed 7 scheduled IDMC reviews with no safety concerns

Dimerix Limited, a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, has announced 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. The ACTION3 Phase 3 study is a pivotal, multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). The trial has opened 219 sites for recruitment across 21 countries, including the US, Europe, UK, Japan, China, Hong Kong, Taiwan, Malaysia, Australia and New Zealand. Notably, in March 2024, Dimerix announced that the ACTION3 Phase 3 trial was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial's first 72 randomised patients. 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 a 94% OLE uptake. 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. 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.

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. 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.