NeuroSense Therapeutics Ltd. announced positive results from its Good Laboratory Practices (GLP) toxicology study designed to evaluate the toxicological profile and toxicokinetics of the combination of celecoxib and ciprofloxacin, the components of PrimeC, the Company's lead combination drug candidate for the treatment of amyotrophic lateral sclerosis (ALS). PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of the two drugs, which are U.S. Food and Drug Administration (FDA)-approved. NeuroSense is currently evaluating PrimeC in PARADIGM, a Phase IIb clinical trial.

The GLP study tested the combination of celecoxib and ciprofloxacin, administered by oral gavage to Sprague-Dawley rats twice daily, for a period of 90 consecutive days. The body weights, body weight gains, and food consumption were unaffected by the treatment at all the doses tested. There were no test item-related changes observed in hematology, coagulation, clinical chemistry, urinalysis, organ weights, gross pathology and histopathology, and neurological examinations.

Animals treated with celecoxib alone, ciprofloxacin alone, or in combination, up to the highest doses tested did not show any adverse toxicological effects. In conclusion, the No Observed Adverse Effect Level (NOAEL) is over 4x the maximal clinical dose.