Argenica Therapeutics (ASX:AGN) wraps up dosing in landmark stroke trial — Eyes 2025 for efficacy reveal

In the high-stakes world of stroke intervention, the final dose has landed.

Perth-based Argenica Therapeutics (ASX:AGN) has reached a major clinical milestone, completing dosing in its Phase 2 trial for ARG-007 — a neuroprotective peptide targeting acute ischaemic stroke.

The last of 92 patients has now received treatment in a study designed to evaluate whether ARG-007 can protect brain tissue following a stroke.

The double-blind trial — involving patients with large vessel occlusion strokes undergoing endovascular thrombectomy — splits participants evenly between the experimental drug and a saline placebo.

Final efficacy and safety assessments will be conducted 90 days after the last dose, with topline results expected in Q3 2025.

Key Highlights
• All 92 patients dosed in Phase 2 trial
• 50/50 split of ARG-007 and placebo recipients
• Endpoints include safety, mortality, adverse events and infarct volume
• Results expected in the second half of 2025

For a company operating in a field where time is quite literally brain, the rapid pace of the trial stands out.

“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,” said Argenica Managing Director Dr Liz Dallimore. “Our trial has outperformed similar trials conducted globally and we are so grateful to all involved.”

The trial’s primary endpoint is safety — tracking mortality, adverse events, and intracranial haemorrhage — while secondary endpoints target the drug’s potential to reduce infarct volume as seen on MRI or CT scans within 48 hours of administration.

Dr David Blacker, Chair of the Clinical Advisory Committee and Co-Principal Investigator, paid tribute to the patients and their families:

“Clinical research is vital to improving treatment of stroke… We look forward to the follow up and analysis leading to further productive collaboration.”

While many clinical trials linger in recruitment limbo, Argenica Therapeutics swift progress — attributed to Australia’s strong stroke research network — could offer the company first-mover momentum in a field with limited treatment options beyond mechanical clot removal.

The outcome of this trial could redefine Argenica’s path — and possibly stroke care — with investors and clinicians alike awaiting the unblinding of the data.

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