Dimerix (ASX:DXB) has announced that the independent Data Safety Monitoring Board (DSMB) has successfully concluded a second review of the ACTION3 phase 3 clinical trial.
The company said that following the routine, scheduled review, the DSMB has noted no safety concerns and recommended that the clinical trial continue as planned.
“The positive recommendations of the DSMB confirm the strong safety profile of DMX-200 previously observed across our multiple clinical studies,” said Dimerix CEO, Dr Ash Soman.
“DMX-200 represents a real hope for the many patients suffering from FSGS kidney disease who currently have limited treatment options. We continue to recruit for Part 2 of the study, and we look forward to reporting on the results of the first analysis in March 2024.”
ACTION3 is a multicentre, randomised, double-blind, placebo-controlled Phase 3 study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients are randomised to receive either DMX-200 (120 mg capsule twice daily) or placebo.
