NeuroSense Therapeutics Concludes Successful Type D Meeting With FDA For ALS Treatment

(RTTNews) - NeuroSense Therapeutics Ltd. (NRSN), a company developing treatments for severe neurodegenerative diseases, Monday announced it has concluded a successful Type D meeting with the Food and Drug Administration (FDA) for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS).

The company said that the FDA agreed with NeuroSense's proposed CMC development plan. PrimeC has already been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA).

"This confirmation from the FDA of our CMC strategy for a future pivotal Phase 3 clinical trial and commercial launch of PrimeC in the treatment of ALS marks a critical milestone in our drug development program. It sets the stage for a smooth transition, particularly as we anticipate clinical efficacy top-line results (secondary endpoints) from our Phase 2b trial very soon," stated Alon Ben-Noon, CEO of NeuroSense.

NeuroSense is currently conducting PARADIGM, phase 2b clinical trial of PrimeC in ALS. Sixty-nine people living with ALS in Canada, Italy, and Israel have been enrolled into PARADIGM, which aims to assess PrimeC's efficacy, as well as safety and tolerability.