AI Imaging Analysis in Acute Ischemic Stroke Trials
Brainomix has announced results from its collaboration with Argenica Therapeutics on imaging and clinical data analysis for a Phase II study evaluating ARG-007, a neuroprotective drug candidate for acute ischemic stroke. The analysis used Brainomix 360 Stroke, an FDA-cleared and CE-marked AI imaging platform, to support standardized baseline assessment and outcome evaluation in patients enrolled in the trial.
According to Brainomix, the AI-enabled approach addressed a key challenge in stroke clinical trials: variability in assessing baseline stroke severity. Differences in manual scoring methods can affect patient stratification and obscure treatment effects. By applying objective, AI-based imaging biomarkers, Brainomix aimed to improve consistency and reliability in evaluating treatment response.
Standardized Baseline Phenotyping With Brainomix 360 Stroke
The Brainomix AI core lab applied regulatory-cleared stroke imaging technology alongside its foundation-model-powered imaging pipeline for clinical trials. This approach enabled robust baseline phenotyping and efficacy analysis across the study population.
Brainomix 360 Stroke provided standardized quantification of imaging biomarkers, including e-ASPECTS, which supported improved stratification of patients based on stroke severity. The analysis confirmed that patients presenting with larger infarcts experienced statistically significant and clinically meaningful improvements when treated with ARG-007 compared with placebo.
Specifically, severe acute ischemic stroke patients showed improvements in neurological function at 24 hours and reduced disability at 90 days. The analysis also demonstrated significantly smaller final infarct volumes in these patients, a key indicator associated with neuroprotective treatment effects.
AI-Enabled Insights Into Treatment Efficacy
The findings demonstrated that AI-based imaging analysis can reveal treatment effects that may not be apparent using conventional assessment methods alone. By reducing variability in baseline severity grading, the Brainomix platform supported a clearer interpretation of clinical outcomes in severe stroke patients.
“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.”
Implications for Future Clinical Development
Argenica Therapeutics highlighted the role of AI-enabled imaging in supporting deeper interpretation of trial data and guiding next development steps.
Dr. Liz Dallimore, CEO and Managing Director of Argenica Therapeutics, said, “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.”
According to Brainomix, the findings will inform future clinical development and patient selection strategies aimed at advancing treatment options for patients with severe acute ischemic stroke.
Source: Brainomix
