NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) has reported receipt of clearance from the United States Food and Drug Administration to begin a pharmacokinetic study of PrimeC in healthy adult subjects. PrimeC is a extended release oral formulation that is composed of unique fixed-dose combination of two FDA approved rugs: ciprofloxacin and celecoxib. PrimceC was granted Orphan Drug Designation by the FDA and the European Medicines Agency as NeuroSense completed a Phase IIa clinical study met its safety and efficacy endpoints that include reducing functional and respiratory deterioration in ALS-related biological markers that indicate PrimeC’s biological activity.
“Data from our Phase IIa clinical study confirmed that PrimeC is a novel therapy with the potential to help people with ALS and address a $3 billion market in need of a more effective treatment,” stated NeuroSense CEO Alon Ben-Noon. “As we prepare to initiate our Phase IIb study in the next few months, the goal of our pharmacokinetic study under FDA IND is to generate additional data on the bioavailability of PrimeC as it relates to food intake in healthy individuals. We are deeply committed to improving the lives of people with ALS and are proud to develop a new potential treatment to address this complex disease.”
Recently, NeuroSense announced the third stage of its collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes to determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets. Results are expected in the second quarter of 2022.