NeuroSense announces Canada approved patient enrollment for PARADIGM study

NeuroSense Therapeutics announced that Health Canada approved the commencement of patient enrollment in Canada for the Company’s Phase 2b PARADIGM study of its combination therapy PrimeC for the treatment of amyotrophic lateral sclerosis, or ALS. Currently, over 50% of patients have been enrolled in PARADIGM with topline results expected in the second half of 2023. The FDA requested additional non-clinical data from NeuroSense to support the duration of the PARADIGM trial, as PrimeC is intended for long-term administration for the treatment of ALS. As a result, and following alignment with the agency on this subject, NeuroSense and the FDA have agreed that NeuroSense will withdraw its study protocol from the Investigational New Drug application, or IND. NeuroSense is planning a formal meeting with the FDA to align its clinical and regulatory strategy for a potential pivotal Phase 3 trial that is intended to support a New Drug Application (NDA) submission, pending the successful conclusion of the PARADIGM trial.