NeuroSense to Hold Pre-NDS Meeting with Health Canada in April 2026

Core Insights - NeuroSense Therapeutics is resuming regulatory advancement for its drug candidate PrimeC in Canada for the treatment of amyotrophic lateral sclerosis (ALS) following a productive discussion with Health Canada [1][2][3] Company Overview - NeuroSense Therapeutics is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's disease, and Parkinson's disease [6] - The company aims to address significant unmet medical needs in neurodegenerative diseases, which currently have limited effective therapeutic options [6] Product Information - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib [5] - The drug is designed to target multiple mechanisms contributing to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation, potentially inhibiting the progression of ALS and Alzheimer's disease [5] Regulatory Progress - Health Canada has outlined the remaining requirements for NeuroSense, confirming that the company's proposed next steps align with the Agency's expectations [2] - NeuroSense is preparing for a pre-New Drug Submission (NDS) meeting with Health Canada, anticipated in April 2026, with a potential NDS submission expected by mid-2026 [2][3] ALS Overview - ALS is an incurable neurodegenerative disease that leads to complete paralysis and death within 2-5 years from diagnosis, with over 5,000 new cases diagnosed annually in the U.S. [4] - The annual disease burden of ALS in the U.S. is approximately $1 billion, and the number of individuals living with ALS is projected to increase by 24% by 2040 in the U.S. and EU [4]