NeuroSense Shares Surge Over 400% As FDA Clears Initiating Pharmacokinetic Study Of PrimeC - NeuroSense Therapeutics (NASDAQ:NRSN)

NeuroSense Therapeutics Ltd NRSN has received clearance from the FDA to initiate a pharmacokinetic study of PrimeC in healthy adult subjects.
PrimeC is a novel extended-release oral formulation composed of a fixed-dose combination of ciprofloxacin and celecoxib.
PrimeC targets several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to inhibit ALS's progression potentially.
PrimeC was granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA).
NeuroSense completed a Phase 2a study that met its safety and efficacy endpoints, including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers.
The Company plans to initiate a Phase 2b study in Q2 2022.
NeuroSense recently announced the third stage of its collaboration with Massachusetts General Hospital to determine further the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets. Results from this study are expected in Q2 2022.
NeuroSense is also advancing programs in Alzheimer's disease for its drug candidate CogniC and Parkinson's disease for StabiliC.
Data from preclinical studies are expected in H2 2022. It expects to initiate clinical studies in these indications in H1 2023.
Price Action: NRSN shares are up 387% at $7.59 during the market session on the last check Monday.