Posted: 12 March 2024
Dimerix Limited (ASX: DXB, “Dimerix”), today announced that the ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomised patients. The analysis indicates that, using a statistical measure,1 DMX-200 is performing better than placebo in terms of reducing proteinuria (a surrogate marker of kidney disease progression6) in patients with FSGS. This analysis is extremely valuable as it is based on a significantly larger cohort than the prior Dimerix Phase 2 study which was conducted in 8 patients.
An interim analysis incorporating a futility assessment (where certain data are assessed early to determine whether or not the drug is having a desired effect) is included to ensure a trial does not
continue unnecessarily if there is no efficacy signal. 3 Therefore passing this first interim analysis (a futility assessment) is important as it suggests that it is possible DMX-200 may achieve a statistically significant and clinically meaningful result at the end of the study.2
