NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA Submission

Core Viewpoint - NeuroSense Therapeutics is advancing its lead product PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS), with a Type C meeting scheduled with the FDA to finalize the Phase 3 clinical trial design and New Drug Application (NDA) readiness [1][2][3] Company Overview - NeuroSense Therapeutics is a late-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's disease [11] - The company aims to address significant unmet medical needs in these areas, where effective therapeutic options are limited [11] Product Development - PrimeC has demonstrated promising results in clinical trials, showing a statistically significant reduction in disease progression and improved survival rates by 43% compared to placebo [5][9] - The drug is a novel extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, targeting multiple mechanisms of ALS [10] - NeuroSense completed a Phase 2a clinical trial for PrimeC, meeting safety and efficacy endpoints, and received Orphan Drug Designation from the FDA and the European Medicines Agency [10] Regulatory Strategy - The FDA Type C meeting on November 6, 2024, will focus on the Phase 3 trial design and NDA submission strategy [2] - NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026, estimating a market opportunity of $100 million to$150 million in annual revenue in Canada [4][6] Clinical Trial Insights - The PARADIGM trial, a Phase 2b study, included 68 participants and showed a 37.4% difference in ALS Functional Rating Scale-Revised (ALSFRS-R) scores in favor of PrimeC compared to placebo [9][8] - A significant majority (96%) of trial participants opted to continue treatment with PrimeC after the double-blind portion of the trial [8] Market Context - ALS is an incurable neurodegenerative disease with a significant annual disease burden of $1 billion in the U.S., with over 5,000 new diagnoses each year [6] - The number of individuals living with ALS is projected to increase by 24% by 2040 in the U.S. and EU, highlighting the urgent need for effective treatments [6]