NeuroSense Therapeutics Scales-Up Production Of PrimeC To Commercial Scale, Following Phase 2B PARADIGM Study

NeuroSense Announces Global CDMO Selection and Manufacturing Scale-Up, Enabling Rapid Pathway to Commercialization for What is Projected to be a $100-150M Canadian Market Opportunity

CAMBRIDGE, Mass., May 7, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study.

NeuroSense has strategically bolstered its supply chain by implementing comprehensive Chemistry, Manufacturing, and Controls (CMC) enhancements that positions the company for a robust and expeditious commercial launch. The company has established a resilient manufacturing infrastructure supply chain by fully qualifying U.S. and Canadian Drug Master File (DMF) and Certificate of Suitability (CEP) holders for both of its Active Pharmaceutical Ingredients (APIs). These steps enable dependable and compliant sourcing for commercial-scale production volumes.

Additionally, the Company is pleased to report that it is partnering with a global Contract Development and Manufacturing Organization (CDMO) that currently manufactures PrimeC clinical batches and will also support its future commercial supply. All analytical methods supporting drug product release and stability have been fully validated, and the manufacturing process has been successfully scaled to commercial levels. Stability data support a shelf life of at least 36 months at room temperature, and formulation IP granted in 2023 provides protection through 2042.

NeuroSense is actively working to advance discussions with Health Canada to pursue early market entry through the Notice of Compliance with Conditions (NOC/c) pathway, a regulatory mechanism designed to expedite access to promising therapies for serious conditions with significant unmet medical needs. While commercial forecasts suggest potential peak annual revenue of $100–150 million in Canada, early market entry would not only address an urgent medical need but also provide valuable real-world data and a strategic foundation for global expansion and reinforce NeuroSense's long-term growth strategy and market position.