Argenica Therapeutics gains ethics approval for phase 1 clinical trial of stroke drug ARG-007

Perth-based biotechnology company Argenica Therapeutics (ASX: AGN) has gained ethics approval to commence a pivotal phase 1 clinical trial of lead drug ARG-007 in healthy participants.

ARG-007 is being developed as a novel therapeutic to reduce brain tissue death after stroke with potential to enhance recovery once a stroke has taken place.

Approval for the trial was granted following an application to Australian research ethics company Bellberry, which exists to protect the welfare of participants in human research projects and ensure the quality, efficiency and effectiveness of that research.

Argenica’s trial will be run by local company Linear Clinical Research at a dedicated Perth facility.

Linear has commenced the process of recruiting up to 32 healthy volunteers, with dosing of the first cohort scheduled for October.

Trial structure

The phase 1 trial will be structured using four groups of eight participants, each of whom will be randomly assigned to receive ARG-007 or a matching placebo administered as a single intravenous dose on day one.

Participants will be enrolled into sequential groups with the first group receiving the lowest dose of ARG-007 or placebo, while remaining groups will receive slightly higher doses.

Safety data from the first group will be reviewed by a committee prior to escalating the dose for subsequent groups.

Each group will include two sentinel subjects, one of whom will be assigned to ARG-007 and the other to the placebo.

Sentinel subjects will be dosed one day prior to remaining participants in the group and monitored for 24 hours.

If the dose is considered to be well-tolerated after that period, the remaining six participants in each group will then be dosed.

Safety, tolerability, pharmacokinetics (regular blood samples) and immune response assessments will be recorded.

Stroke statistics

According to statistics, every 19 minutes someone in the world has a stroke.

In 2019, that equated to 13 million people globally.

During a stroke, a lack of oxygen (hypoxia) caused by the blockage of blood vessels kills 1.9 million brain cells per minute.

Medical interventions available to stroke patients are limited and focus on removing the clot chemically or mechanically, using anticoagulants and thrombolytic drugs to break down the clot causing the blockage.

Approximately 35% of all patients with acute stroke arrive at hospital within the critical 4.5 hour window for treatment.

Failure to hit this narrow timeframe is associated with poor clinical outcomes and long-term health issues.

There is currently no neuroprotective drug on the market which can slow the effects of hypoxia in the brain.

ARG-007 development

The ARG-007 compound was developed by researchers at the University of Western Australia and the Perron Institute for Neurological and Translational Science and has demonstrated improved outcomes in pre-clinical models of stroke.

These preliminary results spurred the incorporation of Argenica in late-2019 to develop and commercialise the drug.