Posted: 11 August 2023
Dimerix Limited (ASX: DXB) a biopharmaceutical company with late-stage clinical assets in inflammatory diseases, today confirmed that the independent Data Safety Monitoring Board (DSMB) has successfully concluded a second review of the ACTION3 phase 3 clinical trial. Following the routine, scheduled review, the DSMB has noted no safety concerns and recommended that the clinical trial continue as planned.
Undertaking a review by an independent DSMB is consistent with good clinical practice, 6 and was prespecified in the analysis plan. The primary responsibilities of the DSMB 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 study protocol for the ACTION3 clinical trial includes oversight by a DSMB as well as provision for interim safety reviews, the second of which has now been successfully completed.
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), multicentre, 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). Once the ARB dose is stable, patients will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.
The single Phase 3 trial in FSGS patients has two 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 accelerated marketing approval. A successful outcome in the first interim analysis outcome, expected on or around 15 March 20241, would see the Company announce a clinically significant and statistical meaningful improvement in proteinuria in patients on DMX-200 versus placebo and that the trial is continuing to Part 2.
