Dimerix (ASX:DXB) has announced that data from the first 72 patients randomised in the ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) has successfully been collected.
The data has been collected ahead of the first interim efficacy and safety analysis and review by the independent Data Safety Monitoring Committee (IDMC) in March 2024.
The company said it expects to report on the part one analysis outcome on, or before, 15th March, following the planned IDMC meeting.
“We are absolutely delighted to have reached this important milestone. I would like to thank all of our patients for agreeing to be part of this trial to date, as well as our CRO and our amazing Dimerix team. We are now only a matter of days away from our Part 1 analysis outcome and, on the presumption of success, are continuing to prepare for Part 2 of the Phase 3 study. Success in Part 1 would signal that DMX-200 is performing better than placebo in reducing proteinuria, an important marker of kidney disease progression, in a larger cohort of patients than our prior Phase 2 study and validates our strategy and our prioritisation of this potentially valuable program.” said Dr Nina Webster, Dimerix CEO and managing director.
Dimerix said it is expected that the complete ACTION3 Phase 3 trial will enrol a total of approximately 286 patients, with a second interim analysis planned after the first 144 patients complete approximately 35 weeks.
