NeuroSense rises 16% on U.S. FDA clearance to begin trial of ALS treatment

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• NeuroSense Therapeutics (NASDAQ:NRSN) is trading 16.5% higher after it said on Tuesday the U.S. Food and Drug Administration had cleared its Investigational New Drug to begin trial of Phase 2b study for its lead drug candidate PrimeC to treat amyotrophic lateral sclerosis (ALS).
• The trial, dubbed Paradigm, is currently enrolling patients in Israel, and NeuroSense expects to open clinical sites for patient recruitment in the European Union in the coming weeks.
• PrimeC is designed to target several key ALS mechanisms that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS.
• The study will enroll 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively.
• NeuroSense expects to enroll and dose the first U.S. patients in the next few weeks at leading ALS centers on both the east and west coast.