Dimerix (ASX:DXB) has announced that an independent Data Safety Monitoring Board (DSMB) has successfully concluded a review of the ACTION3 phase 3 clinical trial.
Dimerix is developing late-stage clinical assets in inflammatory diseases.
The pivotal trial is a multicentre, randomised, double-blind, placebo-controlled trial of the efficacy and safety of DMX-200 in patients with Focal Segmental Glomerulosclerosis (FSGS) kidney disease 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 randomised to receive either DMX-200 or placebo.
Following the routine, scheduled review, the DSMB has noted no safety concerns and recommended that the clinical trial continue as planned.
“The DSMB’s positive recommendation is a key milestone, which enables us to continue patient enrolment as planned and to complete the trial as soon as possible. The outcome from this DSMB analysis is entirely consistent with existing and growing strong safety profile of DMX-200. We have seen strong recruitment momentum across the study, and we look forward to reporting on the results of the interim analysis once the first 72 patients reach 35 weeks treatment,” said Dr Ash Soman, Dimerix chief medical officer.