Core Viewpoint - NeuroSense Therapeutics is advancing its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis (ALS) following a productive Type C meeting with the FDA, which is a significant step towards commencing a Phase 3 clinical study in mid-2025 [1][2][4]. Company Developments - The FDA provided positive feedback on the trial design for the planned Phase 3 study, which is crucial for meeting regulatory expectations and potentially securing drug approval [2][4]. - NeuroSense plans to submit a final protocol to the FDA in the first half of 2025, aiming to enroll approximately 300 patients in a randomized, double-blind, placebo-controlled Phase 3 study [3][4]. - The Phase 3 study will evaluate the efficacy and safety of PrimeC, with participants transitioning to an open-label extension after 12 months of treatment [3][4]. Clinical Trial Insights - The completed Phase 2b PARADIGM study demonstrated PrimeC's significant impact on slowing disease progression and increasing survival rates in ALS patients [1][5]. - The PARADIGM trial involved 68 participants across multiple countries, with a design that included a 12-month open-label extension [7][8]. - Most participants in the trial were concurrently treated with Riluzole, indicating that PrimeC may offer benefits beyond the current standard of care [9]. Product Information - PrimeC is an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, targeting multiple mechanisms of ALS [10][11]. - The drug has received Orphan Drug Designation from both the FDA and the European Medicines Agency, highlighting its potential in addressing an urgent medical need [11]. Industry Context - ALS is an incurable neurodegenerative disease with a significant annual disease burden of $1 billion in the U.S., and the number of diagnosed cases is expected to grow by 24% by 2040 [6].
NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC