NeuroSense reports FDA clearance to initiate Phase 3 trial for PrimeC in ALS

NeuroSense (NRSN) Therapeutics announced that the U.S. Food and Drug Administration has completed the review of the Investigational New Drug amendment application and authorized the company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis, or ALS. “With the FDA’s clearance, NeuroSense is preparing for trial initiation and aims to have its first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial. The global pivotal Phase 3 trial, PARAGON, is powered at over 95% to achieve its primary endpoint and to expand upon the results of NeuroSense’s Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favorable safety and tolerability profile,” the company stated. “This FDA clearance marks a meaningful advancement for NeuroSense and for people living with ALS. We believe this progress lays a strong foundation for additional achievements across several fronts in the near future. We recognize the significant unmet need of people living with ALS and remain committed to delivering a meaningful therapy through our efforts,” added Alon Ben-Noon, Chief Executive Officer of NeuroSense.