DIMERIX LIMITED Dimerix Limited confirmed that recruitment of the first 72 patients to its DMX-200 ACTION3 phase 3 trial in patients with FSGS kidney disease had been achieved. 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 will immediately continue to recruit patients for Part 2 of the trial, as well as to allow for any screen failures and/or patients who drop out or do not comply with the clinical trial protocol.
Part 1 of the trial will conclude after the first interim analysis, once 72 patients have completed 35 weeks of treatment, and is expected to occur in the latter half of 2023. The ACTION3 Phase 3 trial is recruiting across over 70 sites in 11 different countries. 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.
Part 1 interim analysis of the trial data will conclude once 72 patients have completed 35 weeks treatment. With Part 1 recruited, the trial will continue to recruit and randomise a further 72 patients at all activated clinical sites for Part 2 of the trial effective immediately, to reach a total of 144 patients for the second potential Accelerated Approval data analysis. Patients recruited into the trial will need to demonstrate a minimum of 6 weeks stable dosing of an angiotensin receptor blocker prior to randomisation and dosing with DMX-200 or placebo.
The Phase 3 trial, which is titled "Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis" Â or ACTION3 for short, is a pivotal (Phase 3), multi-centre, 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, will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.
