Brainomix, a global leader and pioneer of AI-powered imaging biomarkers for stroke and lung fibrosis, today announced results from its partnership with Argenica Therapeutics (ASX: AGN) for imaging and clinical data analysis of the Phase II trial evaluating ARG-007, a neuroprotective agent for acute ischemic stroke. Analysis using Brainomix 360 Stroke, an FDA-cleared and CE-marked AI-imaging platform, confirmed statistically significant and clinically meaningful efficacy of ARG-007 in severe acute ischemic stroke patients through accurate and standardized quantification of digital imaging biomarkers, including e-ASPECTS which allowed for improved stratification of patients.
The analysis addressed a fundamental challenge in stroke clinical trials: variability in baseline stroke severity assessment. By applying standardized, objective AI imaging biomarkers to the trial data, Brainomix 360 Stroke confirmed that patients with larger infarcts (brain tissue death) at presentation experienced statistically significant improvements in neurological function at 24 hours and disability outcomes at 90 days when treated with ARG-007 compared with placebo. Brainomix also showed that these patients demonstrated significantly smaller final infarct volumes, a key hallmark of neuroprotection.
“This collaboration highlights the value of proactively incorporating AI-enabled precision imaging in clinical trial design and analysis of stroke research,” said Dr. Michalis Papadakis, CEO and co-founder of Brainomix. “Clinical trials in stroke rely heavily on accurate baseline assessments and manual scoring methods, which can introduce variability that obscures true treatment effects. Our Brainomix 360 Stroke platform provides standardized, objective measurements that help identify responsive patient populations with greater precision and, ultimately, accelerate the path to effective therapies for stroke patients. For ARG-007, by standardizing stroke assessment, AI removed variability and exposed a treatment effect that was previously hidden.”
Dr. Liz Dallimore, CEO and Managing Director of Argenica Therapeutics, added, “We are excited by the outcomes of this analysis from Brainomix. Their expertise and AI-enhanced imaging platform allowed us to gain deeper insights from our clinical trial data, providing greater clarity around treatment effects and enabling more detailed exploration of key biomarkers, and show that ARG-007 delivers real benefit where it is needed most, in patients with the largest, most disabling strokes.
“With AI, we can now design a next-phase study of ARG-007 using precision medicine principles, selecting patients based on objectively measured brain injury and maximizing the chance of meaningful recovery.”
