NeuroSense Therapeutics Ltd. announced the completion of enrollment in PARADIGM, a multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial of PrimeC in people living with amyotrophic lateral sclerosis (ALS). Study participants are dosed for 6 months after being randomized 2:1 to receive PrimeC or placebo, respectively, followed by a 12-month open label extension (OLE) phase, during which they receive PrimeC. NeuroSense anticipates topline results in Fourth Quarter 2023.

The study enrolled 69 participants living with ALS in Israel, Italy, and Canada. PrimeC has Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As a novel combination therapy of two FDA approved drugs, celecoxib and ciprofloxacin, with well-established safety profiles, PrimeC is designed to synergistically target several key ALS mechanisms that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS.

The primary efficacy endpoint of PARADIGM, (NCT05357950), is the assessment of ALS-biomarkers to evaluate PrimeC and its biological activity. Secondary endpoints include the clinical outcome measures Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Slow Vital Capacity (SVC), and overall survival, as well as safety and tolerability, in addition to a robust battery of additional biomarkers including neurofilaments. Participants have the option to enroll in a 12-month OLE phase, during which they receive PrimeC.

To date, 26 participants completed the 6-month double-blind phase of the trial and 25 of them chose to continue into the OLE. The results of the Phase 2b PARADIGM clinical trial will inform the design of a future pivotal Phase 3 clinical trial of PrimeC.