Brainomix has announced results from its partnership with Argenica Therapeutics involving imaging and clinical data analysis of a phase two trial evaluating ARG-007—a neuroprotective agent for acute ischaemic stroke. Analyses using the US Food and Drug Administration (FDA)-cleared and CE-marked Brainomix 360 Stroke artificial intelligence (AI) imaging platform confirmed “statistically significant and clinically meaningful” efficacy of ARG-007 in severe acute ischaemic stroke patients through accurate and standardised quantification of digital imaging biomarkers, including e-ASPECTS, which allowed for improved stratification of patients, according to Brainomix.
The company notes in a press release that the analysis addressed a “fundamental challenge” in stroke clinical trials: variability in baseline stroke severity assessment. By applying standardised, objective AI imaging biomarkers to the trial data, Brainomix 360 Stroke confirmed that patients with larger brain infarcts at presentation experienced statistically significant improvements in neurological function at 24 hours and disability outcomes at 90 days when treated with ARG-007 versus placebo. The platform also showed that these patients demonstrated significantly smaller final infarct volumes, which is 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 Michalis Papadakis, chief executive officer (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 standardised, 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 standardising stroke assessment, AI removed variability and exposed a treatment effect that was previously hidden.”
“We are excited by the outcomes of this analysis from Brainomix,” added Liz Dallimore, CEO and managing director of Argenica. “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 maximising the chance of meaningful recovery.”
