NeuroSense Unveils Accelerated, Capital-Efficient Strategy to Advance PrimeC Toward Potential Approval in ALS

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. AI-enabled characterization of PrimeC's formulation advantage. PrimeC is an extended-release fixed-dose combination engineered to synchronize the pharmacokinetic profiles of its two active components. In a completed clinical pharmacokinetic study, PrimeC produced a synchronized exposure profile that was not reproduced when the individual components were administered together. NeuroSense is now applying AI-enabled modeling to these clinical data to quantify the magnitude of that difference, assess its consistency across individual patients and further characterize the contribution of PrimeC's proprietary formulation. This work builds upon PrimeC's established intellectual property position and is intended to support potential additional patent protection while providing clinicians, payers and prospective partners with an objective basis for distinguishing PrimeC from any co-administration of its individual components. A direct comparative study against edaravone. NeuroSense plans to conduct an active-comparator clinical study designed to evaluate PrimeC directly against edaravone, an established ALS therapy. Head-to-head trials are not common in ALS, and differentiated results could provide people with ALS, clinicians, payers and prospective partners with compelling evidence of PrimeC's relative clinical value and commercial potential. A streamlined pivotal pathway. NeuroSense is evaluating an optimized design for its planned Phase 3 study (PARAGON) that would be substantially smaller and shorter in duration than previously planned, enriched for participants earlier in their disease course and intended to support an earlier regulatory submission. Any such pivotal design remains subject to alignment with FDA. The Company plans to discuss with the FDA whether its existing data may support full approval or, alternatively, an Accelerated Approval pathway, with an additional study conducted post-approval as required. A parallel path to earlier access in Canada. NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which the Company continues to ...