Argenica Therapeutics has received ethics approval to commence a Phase 1 clinical trial of healthy participants for a potential stroke treatment.

Linear Clinical Research will be running the trial at its dedicated facility in Perth and will start the process of recruiting healthy volunteers for the trial.

ARG-007, the lead neuroprotective peptide candidate developed by researchers at the Perron Institute and The University of Western Australia (UWA), will be tested for safety, tolerability and pharmacokinetic effects.

Argenica Therapeutics Chief Executive Officer and Managing Director Dr Liz Dallimore said: “We are delighted to have received ethics approval for our first clinical study of ARG-007.

“This is a pivotal moment for Argenica, as we take groundbreaking research from the Perron Institute and UWA into the clinic. We look forward to working with Linear on this trial and providing regular updates as we progress through each cohort.”

Up to 32 subjects will be randomly divided into four cohorts and receive four ascending doses of ARG-007 or a placebo. The site staff treating the subjects and the subjects (volunteers) will be unaware of which treatment is being administered.

Following dosing of the first cohort safety data will be reviewed by a Scientific Review Committee prior to the administration of next ascending dose.

Every 19 minutes someone in Australia will suffer a stroke, and there are currently no neuroprotective treatments that minimise brain injury after a stroke.

Argenica Therapeutics is a biotechnology company set up as a spin-off from UWA and Perron Institute to develop novel therapeutics to reduce brain tissue injury after a stroke and improve patient outcomes. Their lead candidate, ARG-007, developed by Professors Bruno Meloni and Neville Knuckey and their team, has successfully shown improved outcomes in preclinical stroke models.

“Commencing Phase 1 clinical trials is a significant milestone,” Professor Meloni said.

“We have been working toward this goal for almost a decade now. I’m incredibly proud of what we have achieved so far.”

The aim is for the therapeutic to be administered by first responders to protect brain tissue against damage during a stroke.

Dosing of the first cohort of volunteers is expected to begin in October.