NeuroSense’s Phase 2b ALS trial achieves safty and efficacy endpoints

NeuroSense met its primary safety and tolerability endpoints and achieved secondary clinical efficacy endpoints in the top-line results of its randomized, placebo-controlled, double-blind segment the company’s Phase 2b amyotrophic lateral sclerosis – ALS – trial of PrimeC. The trial’s secondary clinical efficacy outcome measure endpoints included Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised and Slow Vital Capacity – SVC -, a measure of respiratory function. NeuroSense expects to report an additional primary biomarker endpoint of the assessment of ALS hallmarks, TDP-43 and Prostagladin2, to evaluate PrimeC’s biological activity, in the first half of 2024 following the completion of the analysis of participants’ plasma. Over the course of 6 months, patients treated with PrimeC experienced a slowing of disease progression, including preserved daily function. The clinical efficacy results showed a 29% difference in favor of PrimeC in ALSFRS-R and a 13% difference in favor of PrimeC in SVC. The safety and tolerability profile of PrimeC was comparable to the placebo. NeuroSense expects to report results from a strategic collaboration with Biogen 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.