NeuroSense completes dosing in Phase 2b ALS clinical trial of PrimeC

NeuroSense Therapeutics (NRSN) announced it has completed dosing of the last patient in the double-blind segment of its Phase 2b amyotrophic lateral sclerosis trial of PrimeC. PrimeC is designed to synergistically target several key ALS mechanisms that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to inhibit the progression of ALS. PrimeC has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency. The company expects to release clinical efficacy results (secondary endpoints) from the double-blind segment of the trial in December 2023. The company expects to report on another primary endpoint, the assessment of ALS-biomarkers, TDP-43 and Prostagladin2, to evaluate PrimeC’s biological activity, in H1 2024 following the completion of the ongoing analysis of patients’ plasma. PrimeC was previously observed to have a statistically significant impact in TDP-43 and Prostagladin2, in NeuroSense’s previous Phase 2a trial. Additionally, in the first quarter of 2024, the company expects to report results from a strategic collaboration with Biogen (BIIB) that is evaluating the impact of PrimeC on patients enrolled in PARADIGM. Under this collaboration, Biogen is to meaningful biomarker analysis and upon receipt of results, has the right of first refusal to co- fund this develop/commercialize PrimeC for the treatment of ALS for a limited time following the results.