Dimerix’ ACTION3 Phase III trial successfully passes first interim analysis

The ACTION3 Phase III 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 randomized patients, Melbourne, Australia-based Dimerix Limited (ASX: DXB) revealed today.

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 progression) in patients with FSGS. This analysis is extremely valuable, according to Dimerix, as it is based on a significantly larger cohort than the prior Dimerix Phase II study which was conducted in eight 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.

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. ACTION3 Phase III clinical trial continues as planned.