NeuroSense Therapeutics Ltd., a company developing treatments for severe neurodegenerative diseases,announced that it has enrolled and dosed the first healthy volunteer in its pharmacokinetic (PK) study 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.