NeuroSense Completes Enrollment in Phase 2b ALS Clinical Trial

NeuroSense Therapeutics, a company developing treatments for severe neurodegenerative diseases, today 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 Q4 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.

“It is highly encouraging that nearly all participants who completed the study have elected to continue in the OLE phase with the treatment of PrimeC,” stated Prof. Vivian Drory, Principal Investigator of the PARADIGM trial at Tel Aviv Sourasky Medical Center. “We look forward to seeing the topline data from this study which uses an optimized formulation of PrimeC. Based on the new formulation, we are aiming for efficacy and safety results that will meet and exceed the results achieved in the Phase 2a study which was conducted here at Sourasky Medical Center.”

“PARADIGM is tracking 17 different outcome measures while the primary endpoint remains focused on biomarkers. This wealth of outcome data will not only be used to optimize the design of a future pivotal Phase 3 study for PrimeC, but we believe it will provide greater insight into the mechanisms of ALS for the scientific community as we advance toward a day when ALS will become a highly treatable disease,” stated NeuroSense’s Chief Medical Officer, Dr. Ferenc Tracik.

“We are pleased to share this milestone for the PARADIGM clinical trial,” stated NeuroSense CEO, Alon Ben-Noon, “We are grateful to the participants living with ALS, their families, and the study investigators for their commitment to the PARADIGM trial and for taking part in our mission to develop an effective therapy for ALS.”