NeuroSense reports statistically significant efficacy in Phase 2b ALS Trial

NeuroSense (NRSN) reported additional positive efficacy data from further evaluation of its Phase 2b trial with NeuroSense’s lead drug candidate for amyotrophic lateral sclerosis – ALS -, PrimeC. Evaluation of top-line results from the PARADIGM trial revealed a statistically significant slowing of disease progression with a 37.4% difference in the gold standard ALS tracking measure in favor of PrimeC vs placebo, and 17.2% difference in Slow Vital Capacity, in favor of PrimeC vs placebo. The trial’s primary endpoints include: safety and tolerability, and ALS-related biomarkers TDP-43 and Prostagladin2. The trial’s secondary endpoints include: clinical efficacy outcome measures, ALSFRS-R and SVC. ALSFRS-R is the most widely used ALS tracking tool accepted by the FDA.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. In addition, the trial met its primary endpoint of safety and tolerability with results comparable to placebo, establishing a solid safety profile for PrimeC. NeuroSense expects to report results from a strategic collaboration with Biogen (BIIB) in January 2024, evaluating the impact of PrimeC on neurofilament levels in participants enrolled in PARADIGM. Upon receipt of results, Biogen has the right of first refusal to co-develop/ commercialize PrimeC for the treatment of ALS for a limited time following the results. The company expects to report primary biomarker endpoints of ALS hallmarks TDP-43 and Prostagladin2, to evaluate PrimeC’s biological activity and target engagement, in the first half of 2024 following the completion of the analysis of participants’ plasma. An End of Phase 2 meeting with the FDA and a Scientific Advice meeting with EMA to discuss these results and to determine the best path forward for PrimeC’s development is expected in the first half of 2024.