NeuroSense Shares Surge Over 400% As FDA Clears Initiating Pharmacokinetic Study Of PrimeC

NeuroSense Shares Surge Over 400% As FDA Clears Initiating Pharmacokinetic Study Of PrimeC
  • 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.

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