NeuroSense Therapeutics Ltd (NASDAQ:NRSN), a late-clinical stage biotechnology company developing novel treatments for neurodegenerative diseases, announced on Monday a redesigned development plan for PrimeC in amyotrophic lateral sclerosis (ALS), which it says is 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.

According to NeuroSense, 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. The company said that together, these clinical, biomarker and regulatory advances provide the foundation for a more focused and capital-efficient development pathway.

PrimeC is an extended-release fixed-dose combination engineered to synchronise the pharmacokinetic profiles of its two active components. In a completed clinical pharmacokinetic study, PrimeC produced a synchronised exposure profile that was not reproduced when the individual components were administered together. NeuroSense is now applying AI-enabled modelling to these clinical data to quantify the magnitude of that difference, assess its consistency across individual patients and further characterise the contribution of PrimeC's proprietary formulation.

This work builds on 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.

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.

Separately, 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 target for December 2026. If accepted and ultimately approved, this pathway has the potential to make PrimeC available to Canadian patients on the strength of data already generated.