Dimerix (ASX:DXB) has announced the recruitment of the first patient to its DMX-200 phase 3 trial in patients with focal segmental glomerulosclerosi (FSGS) kidney disease.
The company said the ACTION3 Phase 3 trial will recruit across 75 sites in 12 different countries globally, with ethics and regulatory submissions having been made in all 12 countries and all activated sites proactively screening for suitable patients.
“This is a significant step forward for Dimerix with recruitment of the first patient into our key Phase 3 ACTION3 FSGS kidney clinical trial. We also expect first dosing in the trial to commence imminently,” said CEO and managing director Dr Nina Webster.
“The potential commercial opportunity for Dimerix in this space is very material, given over US$55 billion is estimated to having been spent on end stage renal failure in the US Healthcare system alone in 2021 and the US Government has issued incentives for physicians to delay patient progression to renal failure as a priority.
“If successful, our drug candidate could make a huge difference globally to patients with this illness and given we have orphan drug designation status, a potential fast track to commercialisation is available – highlighting the compelling nature of this trial for the Company.”
Dimerix said the single Phase 3 trial in FSGS patients has two interim analysis points built-in that are designed to capture evidence of proteinuria and kidney function (eGFR slope), aimed at generating sufficient evidence to support accelerated marketing approval.
Part one of the trial will conclude after the first interim analysis, once 72 patients have completed 35 weeks of treatment, and is expected to occur in the first half of 2023, subject to recruitment.
The trial will continue into Part two with patients recruited into the trial will need to demonstrate a minimum of six weeks stable dosing of an angiotensin receptor blocker prior to randomisation and dosing with DMX-200 or placebo.
