Argenica Therapeutics (ASX:AGN) has unveiled compelling new evidence that its neuroprotective drug candidate, ARG-007, delivers a significant clinical benefit to patients with the most severe forms of acute ischaemic stroke.
The findings come from an advanced AI-enabled reanalysis of the company’s Phase 2 trial, using the FDA-approved Brainomix 360 Stroke platform to standardise baseline stroke severity and clarify treatment effects.
The AI review showed that patients with large infarct cores at presentation experienced statistically significant improvements in neurological function at 24 hours and in disability at 90 days when treated with ARG-007 compared with placebo. These patients also demonstrated significantly smaller final infarct volumes, a key indicator of neuroprotection, particularly evident in those with the largest initial ischaemic injuries.
The analysis revealed that ARG-007’s most substantial impact is in patients with severe strokes, those with poor collateral blood flow or extensive infarct cores, confirming a high-need target population and a substantial commercial opportunity. Patients with smaller infarct volumes showed little difference between treatment arms, consistent with their typically better natural outcomes after thrombectomy.
Managing Director Dr Liz Dallimore said the results strengthen confidence in the drug’s potential to become the first adjunctive neuroprotective therapy for severe stroke patients and will directly inform a precision-medicine Phase 2b trial enriched for those most likely to benefit. Planning for this next stage is now underway.