- Dimerix (DXB) kicks off a Phase 3 clinical study in patients with a rare kidney disease
- Once its first ethics submission has been approved in Australia, patient recruitment can begin for the ACTION3 study to test the efficacy of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS)
- The study will span up to 18 countries, with Australia and New Zealand nominated as the first countries to begin recruitment
- IQVIA has been appointed as the lead contract research organisation to run the study, with preliminary interim analysis anticipated in Q4 2022
- Dimerix shares are up 8.33 per cent, trading at 32.5 cents at 12:11 am AEST
Dimerix (DXB) has kicked off a Phase 3 clinical study in patients with a rare kidney disease.
ACTION3, a study in patients with focal segmental glomerulosclerosis (FSGS), has been launched following its first ethics submission being filed in Australia.
Once the submission is approved, patient recruitment can begin.
The study, titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis”, or ACTION3 for short, is a randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS. The patients will receive a dose of an angiotensin II receptor blocker.
FSGS attacks the kidney’s filtering units where blood is cleared, causing irreversible scarring which can lead to permanent kidney damage and failure, requiring dialysis or transplantation. For those who do receive a kidney transplant, around 40 per cent of patients will have re-occurring FSGS in the new kidney.
Once the dose is stable, patients aged 18 to 75 will be randomised to receive either two capsules of DMZ-200 daily or a placebo.
The study will span up to 18 countries, with Australia and New Zealand pinged as the first countries to start its recruitment across five sites. Sites will be initiated based on several factors, including the speed of regulatory submissions, reviews and COVID-19 status.
Nina Webster, CEO and Managing Director of Dimerix, said the team was delighted to have commenced the operational activities for the ACTION3 study in FSGS patients.
“We are well on track to begin patient recruitment for the study once ethics approval has been achieved, with first patient screening expected to be in Q4 2021,” Dr Webster said.
“We have designed interim analyses into the Phase 3 study design to capture evidence of proteinuria and kidney function improvement during the study, aimed at generating sufficient data to support an accelerated marketing approval.
“With the key regulators’ expectations aligned, including the US FDA and the European EMA, and the encouraging data reported in the prior Phase 2a study, we are excited to deliver on the FSGS program, potentially providing patients with a much-needed treatment option.”
IQVIA has been appointed as the lead contract research organisation to run the study, with preliminary interim analysis anticipated in Q4 2022.
Dimerix shares were up 8.33 per cent, trading at 32.5 cents at 12:11 am AEST