NeuroSense Therapeutics Receives FDA Clearance of IND for PrimeC for the Treatment of ALS

22 March 2022 | Tuesday | News

PrimeC, a novel combination therapy, demonstrated efficacy and safety in Phase IIa study - Phase IIb study expected to commence Q2 2022

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pharmacokinetic study of PrimeC in healthy adult subjects. PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.


PrimeC was granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. The Company plans to initiate a Phase IIb double-blind placebo-controlled multinational study in Q2 2022 with an optimized dose and a unique upgraded formulation. 


The pharmacokinetic study (NCT05232461) is a Phase I open-label, randomized, single-dose, three treatment, three-period crossover study to evaluate the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacin tablets and celecoxib capsules in 12 healthy adult subjects in the US.

"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."  

NeuroSense recently announced the third stage of its collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs) to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets. Results from this study are expected 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  H2 2022, and following an IND submission to the FDA, NeuroSense expects to initiate clinical studies in these indications in H1 2023.


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