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NeuroSense Receives Approval in Germany to Enroll Patients in its Phase 2b ALS Trial
PARADIGM protocol is approved in four countries: Israel, Italy, Canada, and GermanyTopline results expected in H2 2023CAMBRIDGE, Mass., Feb. 8, 2023
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"PARADIGM protocol is approved in four countries: Israel, Italy, Canada, and GermanyTopline results expected in H2 2023CAMBRIDGE, Mass., Feb. 8, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today announced that Germany's Federal Institute for Drugs and Medical Devices (BfArM) approved the Company's Clinical Trial Application (CTA) to enroll patients in PARADIGM, its Phase 2b study of its lead combination drug candidate PrimeC in the treatment of amyotrophic lateral sclerosis (ALS).\nPARADIGM is a Phase 2b randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, with an open-label extension, to evaluate the safety, tolerability, and efficacy of PrimeC. To date, over 50% of the planned 69 study participants have been enrolled.\n\"We expect to enroll the first study participant in Germany in the next few weeks, and we are very pleased to receive regulatory clearance to enroll and dose people living with ALS also in Germany for our PARADIGM study,\" stated NeuroSense's Chief Medical Officer, Dr. Ferenc Tracik. \"We are currently on track to complete enrollment and report data in the second half of this year.\"\nAbout PrimeCPrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicin...