Posted: 15 January 2025
Dimerix Limited (ASX: DXB) a biopharmaceutical company with late-stage clinical assets in inflammatory diseases, today confirmed that the first 144 patients have been randomised in its DMX 200 ACTION3 Phase 3 clinical trial in patients with FSGS kidney disease. Following enrolment into the study, patients are required to complete the background medication stabilisation period, before being randomised to receive either DMX-200 or placebo. With randomisation of the first cohort of 144 patients completed on 27 December 2024 (US time), the blinded interim analysis for this cohort is now scheduled for August 2025, with the Part 2 interim analysis outcome expected to be announced shortly thereafter once laboratory and statistical analysis is complete. The trial continues to recruit patients for the final phase of the trial (target recruitment of 286 patients in total).
Importantly, patients, physicians and Dimerix staff will remain blinded to patient allocation (i.e. which patients are receiving DMX-200 and which are receiving placebo) at all times during study, including at the second interim analysis timepoint, which will assess the statistical powering of the ACTION3 study and confirm study continuation as per protocol based on safety and efficacy assessments1 .The potential for accelerated (or conditional) approval submissions, following the Part 2 interim analysis outcome and any required unblinding, will be assessed based on recommendations of the IDMC and discussions with the appropriate regulatory authorities such as the FDA in the US.
The Phase 3 study, which is titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis”, or ACTION3 for short, is a pivotal (Phase 3), multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomized to receive either DMX200 (120 mg capsule twice daily) or placebo.
The single Phase 3 trial in FSGS patients has interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval. DMX-200 is the most advanced FSGS asset in a Phase 3 clinical trial globally and is attracting strong interest from potential commercial partners.
