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NeuroSense Receives FDA Clearance of IND for its ALS Phase 2b Study
NeuroSense Therapeutics receives FDA clearance to commence patient enrollment in the U.S. with PrimeC, a novel combination therapyFollows a successful U.S.
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[{"type":"text","content":"NeuroSense Therapeutics receives FDA clearance to commence patient enrollment in the U.S. with PrimeC, a novel combination therapyFollows a successful U.S. pharmacokinetic (PK) study which confirmed PrimeC's favorable extended release propertiesCAMBRIDGE, Mass., Nov. 15, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) to enroll patients in the U.S. for its Phase 2b PARADIGM study for its lead drug candidate PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). PARADIGM is currently enrolling patients in Israel, and NeuroSense expects to open clinical sites for patient recruitment in the European Union in the coming weeks. PrimeC has Orphan Drug Designation with the FDA and the European Medicines Agency (EMA).\n\n \n \n \n \n \n \n\n \nAs a combination therapy of two FDA approved drugs with well-established safety profiles, PrimeC is designed to synergistically target several key ALS mechanisms that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS.\nPARADIGM, (NCT05357950), a Phase 2b double-blind, placebo-controlled, multinational clinical trial, aims to assess PrimeC's efficacy, as well as safety and tolerability, in people living with ALS. The study is enrolling and randomizing 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Study participants will be allowed to administer standard of care (SOC) treatment of approved products. Primary and secondary endpoints of the study include assessment of ALS-biomarkers, evaluation of clinical efficacy, and improvement in quality of life. All subjects who complete the 6 month double-blind, placebo-controlled dosing period will be switched to the PrimeC active arm for a 12-month open label extension.\nNeuroSense expects to enroll and dose the first U.S. patients in the next few weeks at leading ALS centers on both the east and west coast.\n\"FDA's acceptance of our IND paves the way for NeuroSense to commence patient enrollment in the U.S. and is another significant milestone achieved in our drug development plan,\" stated Neuro...