Dosing of patients in Argenica Therapeutics’ Phase 2 clinical trial of the neuroprotective drug ARG-007 in acute ischaemic stroke has been completed.
The trial, involving ten hospitals across Australia, involved a total of ninety-two patients with confirmed large vessel occlusion strokes, and who underwent a minimally invasive procedure to remove the clot.
Fifty per cent of the patients received a saline placebo intravenously and the others an intravenous infusion of ARG-007.
WA biotechnical company Argenica’s Phase 2 clinical trial is based on a world-leading discovery by a research team led by Professor Bruno Meloni and Clinical Professor Neville Knuckey and (Perron Institute and The University of Western Australia, pictured).
In ischaemic stroke, the novel therapy ARG-007 could potentially extend the therapeutic time window for medical interventions such as blood clot removal, preserving brain tissue and improving patient outcomes, as well as providing additional neuroprotective benefits post treatment.
Argenica’s ASX announcement said the primary purpose of this clinical trial is to evaluate the safety of a single dose of ARG-007 in participants with acute ischaemic stroke, including mortality rate, incidence of serious adverse events, and incidence of symptomatic intracranial haemorrhage.
The aim, also, is to characterise the effect of ARG-007 on reducing infarct volume (size of brain tissue damage caused by lack of blood supply) in participants with acute ischaemic stroke.
The trial will remain blinded until the final patient dosed has had their follow up functional assessment at 90 days post stroke. This means no one involved knows which patients have had the placebo and which have been dosed with ARG-007.
Topline data is expected to be released in the third quarter of 2025 (calendar year), including data on the safety of ARG-007 and its preliminary efficacy in reducing brain injury following stroke.
Dr Liz Dallimore, Managing Director of Argenica Therapeutics, stated: “We are so delighted to achieve such a significant milestone in the company’s clinical development of ARG-007 in ischaemic stroke, and so quickly.
“The pace of dosing in this trial is a testament to the incredible stroke clinical research capabilities we have in Australia.”
The National Coordinating Principal Investigator of the Phase 2 Clinical Trial is Professor Graeme Hankey, Perron Institute Chair in Stroke at UWA.