28bio's Endurance Study Meets Primary Endpoint, Showing CNS-3D Brain Organoids Predict Clinical Seizure Liability
Results show 83% sensitivity and 89% specificity in predicting whether small molecule drugs will cause clinical seizures
CNS-3D Brain Organoids are 13x more predictive than animal models
Data from 120,551 patients were evaluated in a retrospective non-interventional study
Results to be presented at Society for Toxicology 65th Annual Meeting
NEW ORLEANS, March 23, 2026 /PRNewswire/ -- 28bio today announced the company will present data demonstrating the ability to predict clinical seizure liability in small molecule drugs using human CNS-3D Brain Organoids at the Society for Toxicology (SOT) 65th Annual Meeting in San Diego, CA, March 22-25, 2026.
The Endurance Study is a retrospective, non-interventional study evaluating the predictive performance of CNS-3D Brain Organoids in small molecules with documented human clinical outcomes from 120,551 patients and known positive controls. The study focuses on seizure liability, one of the most challenging and regulatory-critical CNS adverse effects to predict in neurological drug development.
Top-line data to be presented at SOT show 83% sensitivity and 89% specificity in predicting clinical seizure liability across seizure-inducing drugs and clinically safe drugs, outperforming animal models with a 13x higher predictive performance1.
The Endurance Study results also outperform previously published data on 2D and 3D cell-based assays and are in line with guideline-recommendations from regulatory agencies.
"These results show that CNS-3D Brain Organoids can predict human CNS outcomes far more accurately than traditional animal models," said Chris Butt, PhD VP of Technology at 28bio. "By enabling more reliable drugs to advance into first-in-human trials, this technology can reduce clinical failure across neurological drug development."
CNS toxicity accounts for approximately 25%2 of failures across drug discovery and development, yet it is rarely detected during GLP toxicology studies, highlighting the limitations of animal models in predicting human neurological effects.
"FDA and NIH have both emphasized the need for more reliable, human-relevant models in safety assessment and regulatory decision frameworks," said David Weiner, MD, Co-chairman of the Board at 28bio. "With growing regulatory support for new approach methodologies, studies like Endurance demonstrate how CNS-3D Brain Organoids can provide more predictive evidence to guide CNS safety decisions."
The list of presentations by 28bio at SOT 2026 can be found here.
About 28bio
28bio is a neurotechnology company engineering human brains at-scale exhibiting memory, learning, and cognitive functions. Its NexonTM platform integrates tissue engineering, neural interfacing, and AI to reverse today's neurological health crisis by improving the ability to predict which therapies will work in humans. 28bio is committed to advancing ethical standards in the development of brain organoid technology and engineered human cognition. Follow us on LinkedIn.
References
1 Wang, et al. Assessment of a 3D neural spheroid model to detect pharmaceutical‑induced neurotoxicity. ALTEX. 2022; 39(4):560–582.
2 Walker, et al. Drug discovery and development: Biomarkers of neurotoxicity and neurodegeneration. Experimental biology and Medicine 2018; 243: 1037-1045.
SOURCE 28bio
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