NeuroSense Therapeutics has announced a major milestone in its path toward commercializing PrimeC, a potential disease-modifying therapy for ALS. Following promising results from its Phase 2b PARADIGM study, the company has successfully scaled up PrimeC production to commercial levels and partnered with a global CDMO to support both clinical and future commercial supply. With validated analytical methods, a confirmed 36-month shelf life at room temperature, and patent protection through 2042, NeuroSense is now well-positioned to bring PrimeC to market swiftly and reliably.
To support commercialization, NeuroSense has fortified its supply chain by qualifying U.S. and Canadian DMF and CEP holders for both active ingredients in PrimeC. The company is also engaging with Health Canada to pursue early market entry via the Notice of Compliance with Conditions (NOC/c) pathway, aimed at accelerating access to critical therapies. With a projected peak market opportunity of $100–150 million in Canada alone, early launch could not only benefit patients with urgent unmet needs but also provide valuable real-world data to support global expansion.
