- Dimerix (DXB) recruits the first patient to its ACTION3 phase 3 DMX-200 clinical trial in patients with FSGS kidney disease
- The trial is randomised, double-blind and placebo-controlled to evaluate the efficacy and safety of patients with FSGS who are receiving a stable dose of a receptor blocker
- Focal segmental glomerulosclerosis (FSGS) is a disease in which scar tissue develops on the part of the kidneys that filter waste from the blood
- The trial has two interim analysis points that are designed to capture evidence of protein in urine and kidney function
- Shares in Dimerix are steady on the market and are trading at 14.5 cents at 2:21 pm AEST
Dimerix (DXB) has recruited the first patient to its ACTION3 phase 3 DMX-200 clinical trial in patients with FSGS kidney disease.
The trial will be undertaken across 75 sites in 12 countries with ethics and regulatory submissions made in all 12 countries.
The phase 3 trial is randomised, double-blind and placebo-controlled to evaluate the efficacy and safety of patients with FSGS who are receiving a stable dose of a receptor blocker.
Focal segmental glomerulosclerosis (FSGS) is a disease in which scar tissue develops on the part of the kidneys that filter waste from the blood.
There is currently no cure and available therapies are not very effective and are associated with major side effects.
The trial has two interim analysis points that are designed to capture evidence of proteinuria (protein in urine) and kidney function with the aim of generating sufficient evidence to support marketing approval.
Part one of the trial will end after the first interim analysis once 72 patients have completed 35 weeks of treatment. Subject to patient recruitment, this is expected to occur in the first half of 2023.
Under part two, patients will need to demonstrate a minimum of six weeks of stable dosing of a receptor blocker prior to receiving either DMX-200 or placebo.
DMX-200 is a chemokine receptor blocker that is administered to patients taking an angiotensin II type I receptor blocker.
Furthermore, Dimerix has received Orphan Drug Designation for DMX-200 in Europe and the US as well as the equivalent Innovative Licensing and Access Pathway in the UK.
These designations provide regulatory and financial benefits to help bring new drugs to the market faster.
Two additional patent applications were filed globally, protecting DMX-200 until at least March 2041 and January 2042.
“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,” CEO and Managing Director Dr Nina Webster commented.
“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.”
Shares in Dimerix were steady on the market and were trading at 14.5 cents at 2:21 pm AEST.