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Highlights

Final patient dosed in Argenica’s Phase 2 trial of ARG-007 for acute ischaemic stroke.

92 patients enrolled, equally split between ARG-007 and placebo groups.

Trial remains blinded with topline data expected in Q3 2025.

Primary focus on safety; secondary focus on reduction of brain tissue damage.

AGN shares rose 2.99% to 69 cents on the news.

Argenica Therapeutics Limited (ASX:AGN), a clinical-stage biotechnology company developing neuroprotective therapeutics, has successfully completed dosing of all patients in its Phase 2 clinical trial evaluating ARG-007 in patients with acute ischaemic stroke (AIS).

A total of 92 patients with confirmed large vessel occlusion strokes who underwent endovascular thrombectomy were enrolled and dosed. Half of the participants received a placebo saline infusion, while the other half received a single intravenous dose of ARG-007.

Trial Progress and Next Steps

The study is double-blinded, meaning neither patients, hospital staff, investigators, nor Argenica personnel know which treatment was administered. This will remain the case until the final 90-day functional assessment has been completed for the last patient dosed.

Following that, the trial database will be locked and data will be unblinded and analysed. Argenica expects to release topline results, including both primary and secondary endpoints, in Q3 2025.

Study Endpoints

Primary Endpoint: Safety of ARG-007, including rates of mortality, serious adverse events, and symptomatic intracranial haemorrhage.
Secondary Endpoint: Efficacy of ARG-007 in reducing infarct volume (area of brain tissue damage), measured using MRI or CT scans 48 hours post-treatment.

The trial marks a major milestone in Argenica’s mission to develop a treatment that protects brain tissue during stroke and improves long-term outcomes for patients undergoing clot-removal procedures.