Posted: 9 February 2023
Dimerix Limited a biopharmaceutical company with late-stage clinical assets in inflammatory diseases, today confirmed that an independent Data Safety Monitoring Board (DSMB) has successfully concluded a 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, 7 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 for the ACTION3 clinical trial includes oversight by a DSMB as well as provision for interim reviews, the first of which has now been successfully completed.
The ACTION3 Phase 3 trial is actively recruiting across clinical sites globally, with 96 patients having now been recruited to its DMX-200 Phase 3 trial in patients with FSGS kidney disease as at 7 February 2023 (versus 48 as at 27 October 20228). Once patients have completed the background medication stabilisation period and subsequent re-screening, they are then randomised to receive either drug or placebo. The trial continues to recruit patients for any screen failure, drop out or do not comply with the clinical trial protocol and to support Part 2 of the trial.
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.1 Part 1 interim analysis of the trial data will conclude once 72 patients have completed 35 weeks treatment.
The Phase 3 trial, 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 trial 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, aged 18 to 80 years (broadening to 12 to 80 years following first
successful interim analysis), will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.
