Three-part program - AI-enabled characterization of PrimeC's formulation advantage, an active-comparator trial against edaravone, and a streamlined pivotal pathway - is designed to strengthen PrimeC's differentiation, shorten the time to potential commercialization, and significantly reduce overall development costs, complemented by a parallel regulatory pathway in Canada.

CAMBRIDGE, Mass., Aug. 31, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced a redesigned development plan for PrimeC in amyotrophic lateral sclerosis, structured to reach a potential path for regulatory submission and approval faster and at materially lower cost than the Company's previously planned development path.

ALS drug development has been shaped by a single model: large, long, expensive confirmatory trials that few companies can fund and that people with ALS wait years to read out. NeuroSense's plan replaces that single large commitment with three shorter, focused studies, each designed to answer a specific question that regulators, physicians, partners or payers routinely ask.

The redesigned strategy builds on the totality of evidence generated in NeuroSense's Phase 2b PARADIGM study, including clinically meaningful effects on functional decline, statistically significant modulation of extracellular vesicle-associated TDP-43, consistent findings across multiple disease-related biomarkers, and encouraging long-term survival results. NeuroSense has already received FDA clearance to initiate its pivotal Phase 3 PARAGON trial. Together, these clinical, biomarker and regulatory advances provide the foundation for a more focused and capital-efficient development pathway.