Posted: 27 February 2024
Dimerix Limited (ASX: DXB, “Dimerix”), is pleased to confirm 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 ahead of the first interim efficacy and safety analysis and review by the independent Data Safety Monitoring Committee (IDMC) in March 2024.
The Company expects to report on the Part 1 analysis outcome on, or before, 15th March 2024, following the planned IDMC meeting
In line with best practice for blinded Phase 3 clinical trials, the interim analysis data are only reviewed by the IDMC. Dimerix, the regulatory authorities including the United States Food and Drug Administration (FDA), and the trial investigators are blinded to treatment allocations, grouped safety and efficacy data for the ongoing trial and the data inputs into this interim analysis.
It is expected that the full ACTION3 Phase 3 trial will enrol in total approximately 286 patients, with a second interim analysis planned after the first 144 patients complete approximately 35 weeks. ACTION3 is the only Phase 3 study active in patients with FSGS, in a disease with no approved products.
