First patient recruited in rare kidney disease Phase 3 trial

Our biotech investment, Dimerix Limited (ASX: DXB), has recruited the first patient to its DMX-200 ACTION3 phase 3 clinical trial in patients with FSGS kidney disease.

ACTION3 is a pivotal (Phase 3), multicentre, randomised, double-blind, placebo-controlled trial of the efficacy and safety of DMX-200 in patients with FSGS (Focal segmental glomerulosclerosis) who are receiving a stable dose of an angiotensin II receptor blocker (ARB).

That’s a lot to take in, but this is a significant moment for DXB - Phase 3 is actually happening and a lot of groundwork had to be laid for DXB to get to this point.

The trial will recruit across 75 sites in 12 different countries globally, with ethics and regulatory submissions now made in all 12 countries and those with approvals proactively screening for suitable patients.

Part 1 of the trial will conclude after the first interim analysis, once 72 patients have completed 35 weeks treatment — expected in the first half of 2023 (subject to recruitment).

This dosing and the ethics and regulatory submissions support our #1 Objective for DXB this year: to progress these Phase 3 trials.

What’s next?

We’re looking for further recruitment updates and word that all sites for the study are fully set up.