Dimerix (ASX:DXB) has confirmed that the first 72 patients have been randomised in its DMX-200 ACTION3 phase 3 trial in patients with FSGS kidney disease.
Following recruitment, patients were required to complete the background medication stabilisation period and subsequent re-screening, before being randomised to receive either drug or placebo.
The company said that with randomisation of the first cohort of patients complete, the final data collection is scheduled on 26 February 2024, with the part one interim outcome expected to be announced on, or around, mid-March. It said that the trial continues to recruit patients for Part 2 of the trial.
The study is a Phase 3, multicentre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomised to receive either DMX-200 (120 mg capsule twice daily) or placebo.
“The randomisation of the first 72 patients into our key Phase 3 ACTION3 FSGS kidney clinical trial is a major milestone for Dimerix,” said CEO and managing director, Dr Nina Webster.
“The first patient in the trial was randomised in July 2022, meaning Part 1 randomisation of patients in a rare disease has taken only 12 months. We are delighted to be able to now provide clarity on the anticipated Part 1 data timing. FSGS patients today face poor outcomes with limited medical options, and on success, DMX-200 could be a significant advancement in the treatment of FSGS as well as the first approved treatment available to the FSGS community,” added Dr Webster.
