- NeuroSense Therapeutics Ltd (NASDAQ: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.
