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NeuroSense to Report Phase 2b ALS Topline Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints on December 5, 2023
Data to be announced in a premarket press release followed by a conference call at 8:30 am ET CAMBRIDGE, Mass., Dec. 4, 2023 /PRNewswire/ -- NeuroSense
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":" Data to be announced in a premarket press release followed by a conference call at 8:30 am ET \nCAMBRIDGE, Mass., Dec. 4, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (\"NeuroSense\"), a company developing treatments for neurodegenerative diseases, today announced it will report new data from the randomized, placebo-controlled, double-blind segment of its ongoing Phase 2b amyotrophic lateral sclerosis (ALS) trial (PARADIGM) of its lead drug candidate PrimeC. The data will include primary safety and tolerability endpoints as well as secondary clinical efficacy outcome measures: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and Slow Vital Capacity (SVC).\n\nTo join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and audio archive of the presentation may be accessed on the investor section of NeuroSense's website at https://neurosense.investorroom.com/. The webcast will be available for replay for 30 days.\nAbout ALS\nAmyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.\nAbout PrimeC\nPrimeC, 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 trial which 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. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).\nAbout NeuroSense\nNeuroSe...