NeuroSense Therapeutics (NASDAQ: NRSN) has announced plans to incorporate newly generated data into its New Drug Submission (NDS) to Health Canada for PrimeC, its lead investigational therapy for amyotrophic lateral sclerosis (ALS).
According to NeuroSense, the NDS would be PrimeC’s first marketing application in any jurisdiction, and the company believes the additional data will strengthen the application and expand the evidence available for regulatory review. If approved, PrimeC would receive its first regulatory authorization and would address a population of approximately 4,000 Canadians living with ALS, with approximately 1,000 new diagnoses each year. In parallel, the company is advancing discussions with potential commercialization partners for Canada.
Alon Ben-Noon, CEO of NeuroSense, commented, “Neurofilament light chain is one of the most widely used measures of neuronal injury in ALS, and adding this analysis to the PARADIGM results gives Health Canada a broader body of evidence on which to evaluate PrimeC’s potential benefit for people living with ALS. Canada is our nearest path to patients, and our priority is to submit the most complete application we can. In parallel, we are preparing for the FDA-cleared U.S. Phase 3 PARAGON trial.”
