Biopharmaceutical company Dimerix Limited (ASX: DXB) announced on Monday that it has completed recruitment and dosing of the 286th adult patient in its ACTION3 Phase 3 clinical trial evaluating DMX-200 for focal segmental glomerulosclerosis.

This study assesses efficacy and safety of DMX-200 in combination with standard-of-care angiotensin II receptor blockers over a two-year treatment period.

Of the 286 adult patients dosed, 69 have completed the full two-year treatment, with 65 electing to enter the Open Label Extension study, representing a 94% uptake rate. The trial has passed seven scheduled Independent Data Monitoring Committee reviews with no protocol changes or safety concerns identified.

ACTION3 is a pivotal, multicentre, randomised, double-blind, placebo-controlled study designed to evaluate proteinuria reduction and kidney function decline to support potential regulatory approval. In March 2024, Dimerix reported positive results from a pre-specified interim analysis of the first 72 randomised patients, indicating DMX-200 outperformed placebo in reducing proteinuria.

Following completion of recruitment, Dimerix and US partner Amicus Therapeutics plan to seek U.S. Food and Drug Administration feedback on proposed trial endpoints ahead of blinded data analysis. Recruitment of paediatric patients continues as a separate cohort, which may support future expansion into adolescent indications. The company reported a strong cash position to fund ongoing trial activity and assess additional research and development opportunities.