Dimerix Limited announced it received approval from the US Food and Drug Administration (FDA) on 6 May 2022 (US time) to proceed with the Phase 3 study of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) in the United States. The Investigational New Drug (IND) application for the ACTION3 clinical study is now active, paving the way for patient recruitment in the United States. The ACTION3 Phase 3 study will recruit across 75 sites in 12 different countries globally, with 19 of those clinical sites having been selected in the US.

Ethics and regulatory submissions have been made in all 12 countries, with all activated sites proactively screening for suitable patients. The single Phase 3 study in FSGS patients, which is already recruiting in other territories globally, has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the study, aimed at generating sufficient evidence to support accelerated marketing approval42 Part 1 of the study will conclude after the first interim analysis, once 72 patients have completed 35 weeks treatment, and is expected to occur in the first half of 2023 (subject to recruitment).