Breakthrough in Stroke Treatment: Brainomix AI Validates Novel Neuroprotective Drug

Key Takeaways

• Brainomix 360 Stroke imaging was used to improve and standardize the grading of baseline stroke severity in patients enrolled in Argenica Therapeutic’s Phase II study of neuroprotective ARG-007.
• The Brainomix AI core lab demonstrated efficacy of Argenica’s ARG-007 in severe stroke patients through accurate and standardized quantification of digital imaging biomarkers.
• The analysis addressed a fundamental challenge in stroke clinical trials: variability in baseline stroke severity assessment.
• The use of AI-enabled precision imaging in clinical trial design and analysis can help identify responsive patient populations with greater precision and accelerate the path to effective therapies for stroke patients.
• The findings from the analysis will inform future clinical development and patient selection to advance treatment options for patients with severe acute ischemic stroke.

Introduction to Brainomix and Argenica Therapeutics
Brainomix, a global leader in AI-powered imaging biomarkers for stroke and lung fibrosis, has announced results from its partnership with Argenica Therapeutics for imaging and clinical data analysis of the Phase II trial evaluating ARG-007, a neuroprotective agent for acute ischemic stroke. Argenica Therapeutics is a biotechnology company developing innovative neuroprotective therapies to protect brain cells following stroke, traumatic brain injury, and other neurological conditions. The collaboration between Brainomix and Argenica Therapeutics aimed to improve the grading of baseline stroke severity in patients enrolled in the Phase II study of ARG-007 using Brainomix 360 Stroke imaging.

The Role of Brainomix 360 Stroke Imaging
Brainomix 360 Stroke is the world’s first fully automated AI imaging platform, specifically designed for acute stroke assessment across every stage of the patient pathway. The platform integrates advanced algorithms for NCCT, CTA, CTP, and MRI, enabling faster and more accurate diagnosis and empowering clinicians to make informed decisions that improve patient outcomes. In the Phase II trial of ARG-007, Brainomix 360 Stroke was used to provide robust baseline phenotyping and efficacy analysis, demonstrating statistically significant and clinically meaningful efficacy of ARG-007 in severe acute ischemic stroke patients.

Addressing Variability in Baseline Stroke Severity Assessment
One of the fundamental challenges in stroke clinical trials is variability in baseline stroke severity assessment. Manual scoring methods can introduce variability that obscures true treatment effects, making it difficult to accurately assess the efficacy of new therapies. The use of AI-enabled precision imaging, such as Brainomix 360 Stroke, can help address this challenge by providing standardized, objective measurements that help identify responsive patient populations with greater precision. In the Phase II trial of ARG-007, the Brainomix AI core lab demonstrated that patients with larger infarcts 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.

Implications for Future Clinical Development
The findings from the analysis will inform future clinical development and patient selection to advance treatment options for patients with severe acute ischemic stroke. The use of AI-enabled precision imaging in clinical trial design and analysis can help accelerate the path to effective therapies for stroke patients. By standardizing stroke assessment, AI can remove variability and expose treatment effects that were previously hidden. As Dr. Michalis Papadakis, CEO and co-founder of Brainomix, noted, "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."

Conclusion and Future Directions
In conclusion, the partnership between Brainomix and Argenica Therapeutics has demonstrated the value of AI-enabled precision imaging in clinical trial design and analysis. The use of Brainomix 360 Stroke imaging has provided new insights into the efficacy of ARG-007 in severe acute ischemic stroke patients, and the findings will inform future clinical development and patient selection. As the field of stroke research continues to evolve, the use of AI-enabled precision imaging is likely to play an increasingly important role in the development of new therapies and the improvement of patient outcomes. With the ability to design a next-phase study of ARG-007 using precision medicine principles, selecting patients based on objectively measured brain injury, the future of stroke treatment looks promising.