Core Insights - NeuroSense Therapeutics is seeking early commercialization approval for PrimeC in Canada following positive Phase 2b trial results, which indicate a 36% reduction in ALS disease progression and a 43% improvement in survival rates [1][2][3] Company Overview - NeuroSense Therapeutics is a late-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's [8] - The company aims to address significant unmet medical needs in neurodegenerative diseases through combined therapies targeting multiple pathways [8] Product Details - PrimeC is an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, designed to target mechanisms contributing to ALS progression [7] - The Phase 2b PARADIGM trial involved 68 participants across Canada, Italy, and Israel, with a significant majority opting to continue treatment after the trial [5][6] Clinical Trial Results - The Phase 2b trial demonstrated a statistically significant slowing of disease progression with a 37.4% difference in ALSFRS-R scores in favor of PrimeC compared to placebo [6] - The trial's double-blind segment showed a 29% efficacy difference favoring PrimeC over placebo [6] Regulatory Process - The regulatory submission for PrimeC is based on the recommendations of Canadian regulatory experts and the promising clinical findings from the PARADIGM trial [2][3] - The company plans to seek approval in additional countries following the Canadian submission [1]
NeuroSense Therapeutics Plans to File for Early Commercialization of ALS Treatment in Canada