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NeuroSense Expands its Phase 2b ALS PARADIGM Trial to Canada and Withdraws Protocol from U.S. IND to Align its Clinical Strategy with the FDA for a Potential Pivotal Phase 3 Study
Receives regulatory approval from Health Canada to commence enrollment PARADIGM topline read-out expected H2 2023CAMBRIDGE, Mass., Feb. 6, 2023 /PRNewswire/
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"Receives regulatory approval from Health Canada to commence enrollment PARADIGM topline read-out expected H2 2023CAMBRIDGE, Mass., Feb. 6, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today 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 (ALS). Currently, over 50% of patients have been enrolled in PARADIGM with topline results expected in the second half of 2023.\nDr. Christen Shoesmith, Medical Director of the London Health Sciences Centre ALS Clinic and Principal Investigator of the PARADIGM trial in Canada, commented, \"We are very pleased with Health Canada's approval to recruit and dose people living with ALS in the PARADIGM study. Canada is at the forefront of advancing promising treatments to provide much needed options for people living with ALS.\"\nThe U.S. Food and Drug Administration (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 (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.\n\"Our North American clinical development strategy got a boost from Health Canada, which approved our Phase 2b PARADIGM study to dose patients,\" stated NeuroSense CEO Alon Ben-Noon. \"In the interest of treating and completing dosing of people living with ALS in an expedient and safe manner through PARADIGM, we've focused our North American recruitment in Canada. We look forward to working with the FDA on a path that includes clinical sites in the U.S. in a future Phase 3 pivotal study of PrimeC to address the dire unmet need of the U.S. ALS community who are eager to receive PrimeC for long term use.\"\nAbout PrimeC\nPrimeC...