NeuroSense Therapeutics has redesigned its development plan for PrimeC to treat amyotrophic lateral sclerosis (ALS). The new strategy replaces a single large trial with three focused studies to accelerate regulatory approval. This approach aims to reach the market at a significantly lower cost than the previous model.
The revised plan builds on positive data from the company's Phase 2b PARADIGM study. One AI-enabled study will characterize the unique formulation of PrimeC. A second trial will compare the drug against edaravone, an established ALS therapy. A third streamlined pivotal study will complete the clinical pathway.
NeuroSense is simultaneously seeking earlier market access in Canada. The company completed the pre-New Drug Submission process with Health Canada. It targets a formal filing in December 2026. This separate track could make PrimeC available to Canadian patients while U.S. studies remain ongoing.