NeuroSense Initiates Pivotal Phase 3 Trial for PrimeC in ALS with FDA Clearance

NeuroSense Therapeutics has received FDA clearance to initiate a pivotal Phase 3 trial for its lead drug candidate, PrimeC, to treat amyotrophic lateral sclerosis (ALS). The trial, PARAGON, aims to enroll 300 participants and will be conducted in the US and EU. The trial design has been approved by the FDA, and NeuroSense is preparing for trial initiation with the goal of enrolling its first patient in the coming months.