NeuroSense Therapeutics Ltd. reported additional positive efficacy data from further evaluation of its Phase 2b trial (PARADIGM) with NeuroSense's lead drug candidate for amyotrophic lateral sclerosis ("ALS"), PrimeC. Evaluation of the pre-specified Per Protocol (PP) population analysis of the recent top-line results from PARADIGM revealed a statistically significant slowing of disease progression with a 37.4% (p=0.03) difference in the gold standard ALS tracking measure, the ALS Functional Rating Scale-Revised ("ALSFRS-R"), in favor of PrimeC vs placebo, and 17.2% (p=0.39) difference in slow Vital Capacity ("SVC"), in favor of PrimeC against placebo. The goal of a PP analysis in clinical trials is to assess the efficacy of a treatment under optimal conditions, thereby providing a clearer understanding of how well the treatment works when implemented as intended, contributing to a more comprehensive view of the trial results.

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial.ALSFRS-R is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. SVC is a measurement of respiratory function. While PARADIGM is powered to demonstrate statistically significant changes in the trial's primary endpoints, the highly favorable clinical results seen in the PP analysis achieved an unexpected statistical significance.

NeuroSense completed the 6-month double-blind portion of its Phase 2b ALS clinical trial which met its safety and tolerability endpoints, as well as showing a statistically significant slowing of disease progress in the pre-specified Per Protocol ("PP) population.