NeuroSense Therapeutics Ltd (Nasdaq:NRSN), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announced on Monday that the US Food and Drug Administration (FDA) has completed the review of its Investigational New Drug (IND) amendment application and authorised 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 (ALS).

With the FDA's clearance, NeuroSense is preparing for trial initiation and aims to have the first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial.

According to NeuroSense, the global pivotal Phase 3 trial, PARAGON, is powered at over 95% to achieve its primary endpoint and to expand on the results of the Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favourable safety and tolerability profile.

Based on prior discussions with the FDA and in line with its recent comments and recommendations, PARAGON is expected to be conducted in the United States and European Union and include 300 people living with ALS randomised in a ratio of 2:1 (PrimeC to placebo).