Study of Combination Ciprofloxacin/Celecoxib for Amyotrophic Lateral Sclerosis Starts Enrollment and Dosing 

In the pharmacokinetic (PK) study (NCT05232461) celecoxib/ciprofloxacin therapy (PrimeC; NeuroSense Therapeutics, Herzliya, Israel), the first participant was enrolled and dosed for treatment of amyotrophic lateral sclerosis (ALS).

This study of celecoxib/ciprofloxacin therapy is evaluating the effect of food on absorbtion of the combined therapy vs coadministered ciprofloxacin tablets and celecoxib capsules. The study has an open-label randomized single-dose 3-treatment 3-period crossover design with 12 adult participants under an FDA cleared investigational new drug (IND) protocol.

"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 2b study will assist in designing a pivotal phase 3 trial of PrimeC for the treatment of ALS in alignment with FDA requirements," stated NeuroSense chief executive officer Alon Ben-Noon.

The celecoxib/ciprofloxacin therapy is an extended-release oral formulation of a combination of 2 FDA-approved drugs, ciprofloxacin and celecoxib in a fixed dose. The therapy is made to target ALS components that effect impaired RNA regulation, inflammation, iron accumulation, and motor neuron degeneration to hypothetically deter the progress of ALS.