NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, that it has enrolled and dosed the first healthy volunteer in its pharmacokinetic.
(PK) study (NCT05232461) of its lead combination drug candidate PrimeC developed for the treatment of amyotrophic lateral sclerosis (ALS).
The pharmacokinetic open-label, randomized, single-dose, three-treatment, three-period crossover study is evaluating 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 under an FDA cleared IND protocol.
PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs, ciprofloxacin and celecoxib, and is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS.
"We expect to complete and report data on this pharmacokinetic study in Q3 2022. The combined data from both the PK study and our upcoming Phase IIb study will assist in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements," stated NeuroSense CEO Alon Ben-Noon.
About PrimeC
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. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NueroSense is working 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 Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that it has enrolled and dosed the first healthy volunteer in its pharmacokinetic (PK) study (NCT05232461) of its lead combination drug candidate PrimeC developed for the treatment of amyotrophic lateral sclerosis (ALS).
The pharmacokinetic open-label, randomized, single-dose, three-treatment, three-period crossover study is evaluating 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 under an FDA cleared IND protocol.
PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs, ciprofloxacin and celecoxib, and is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS.
"We expect to complete and report data on this pharmacokinetic study in Q3 2022. The combined data from both the PK study and our upcoming Phase IIb study will assist in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements," stated NeuroSense CEO Alon Ben-Noon.
About PrimeC
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. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NueroSense is working 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.
About ALS
Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the US alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the US and EU.
