• Sixth scheduled IDMC review of ACTION3 phase 3 FSGS trial completed
• IDMC recommends trial continue unchanged with no safety concerns
• Strong emerging safety profile of DMX-200 confirmed

Dimerix Limited, a biopharmaceutical company with late-stage clinical assets in inflammatory diseases, has announced the successful completion of the sixth scheduled Independent Data Monitoring Committee (IDMC) review of the ACTION3 phase 3 clinical trial of DMX-200 in Focal Segmental Glomerulosclerosis (FSGS) kidney disease. Following the routine, scheduled review, the IDMC has noted no safety concerns and recommended that the clinical trial continue as planned, supporting the emerging strong safety profile of DMX-200. Undertaking IDMC reviews is consistent with good clinical practice and was pre-specified in the study protocol. The primary responsibilities of the IDMC are to review and evaluate the available study data for participant safety, study conduct and progress, and to make recommendations concerning the continuation, modification, or termination of the trial. The ACTION3 clinical trial is a pivotal (Phase 3), 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 study is designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval. Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe for FSGS, which qualifies the company for various development incentives and a fast-tracked regulatory pathway to approval.