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NeuroSense Advances Plans For Early Commercialization Of Potentially Groundbreaking ALS Treatment In Canada, Targeting A $100M+ Market
--News Direct--By Kyle Anthony, Benzinga NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing novel treatments
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"--News Direct--By Kyle Anthony, Benzinga NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases – such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease – recently announced its plans to file for early commercialization approval for PrimeC, the firm’s leading drug candidate designed to synergistically target several biological mechanisms of ALS, under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy. This submission is backed by promising results from the company’s phase 2b ALS PARADIGM clinical trial and supplementary clinical and preclinical data.ALS ExplainedALS is a nervous system disease that affects nerve cells in the brain and spinal cord. The disease causes loss of muscle control, and gradually worsens over time. Often called Lou Gehrig's disease after the baseball player who was diagnosed with it, the exact cause of the disease is still not known.ALS often begins with muscle twitching and weakness in the arm or leg, trouble swallowing or slurred speech. Eventually, ALS affects the control of the muscles needed to move, speak, eat and breathe. There is no cure for this fatal disease. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and European Union.The Efficacy Of NeuroSense’s PrimeC TreatmentPrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation with a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several biological mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation. The goal is to inhibit the progression of ALS.NeuroSense reports that PARADIGM, a prospective, multinational, randomized, double-blind, placebo-controlled phase 2b clinical trial of PrimeC in ALS, has demonstrated the drug's efficacy. The trial demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS.The trial i...