NeuroSense Therapeutics has initiated the regulatory process for early commercialization approval of PrimeC under Health Canada's NOC/c policy, following successful Phase 2b trial results. The ALS treatment demonstrated a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo.The PARADIGM Phase 2b trial, conducted across Canada, Italy, and Israel with 68 participants, showed significant efficacy with a 29% improvement in the intent-to-treat population. In the per-protocol analysis, PrimeC achieved a statistically significant 37.4% (p=0.03) difference in ALSFRS-R compared to placebo, demonstrating effectiveness beyond the standard Riluzole treatment.PrimeC, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, has received Orphan Drug Designation from both FDA and EMA. The company plans to expand its regulatory approval efforts beyond Canada, aiming to address the growing ALS patient population, expected to increase by 24% by 2040 in the U.S. and EU.

NeuroSense Therapeutics has initiated the regulatory process for early commercialization approval of PrimeC under Health Canada's NOC/c policy, following successful Phase 2b trial results. The ALS treatment demonstrated a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo.The PARADIGM Phase 2b trial, conducted across Canada, Italy, and Israel with 68 participants, showed significant efficacy with a 29% improvement in the intent-to-treat population. In the per-protocol analysis, PrimeC achieved a statistically significant 37.4% (p=0.03) difference in ALSFRS-R compared to placebo, demonstrating effectiveness beyond the standard Riluzole treatment.PrimeC, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, has received Orphan Drug Designation from both FDA and EMA. The company plans to expand its regulatory approval efforts beyond Canada, aiming to address the growing ALS patient population, expected to increase by 24% by 2040 in the U.S. and EU.