#Canada #Cambridge #ALS #NeuroSense #PrimeC

NeuroSense Therapeutics Achieves Significant Manufacturing Milestone for PrimeC

NeuroSense Therapeutics Ltd., listed on NASDAQ as NRSN, has recently announced a major breakthrough in its production capabilities, bringing it one step closer to releasing its innovative ALS treatment, PrimeC, to the Canadian market. Following compelling results from the Phase 2b PARADIGM study, the company has successfully scaled up its manufacturing processes to meet commercial demands.

This achievement not only underscores NeuroSense's commitment to developing novel treatments for neurodegenerative diseases but also signals the potential for a robust market entry in Canada. The company's manufacturing operations have undergone significant enhancements to ensure compliance and efficiency, setting a solid foundation for the commercial launch of PrimeC.

To facilitate this progress, NeuroSense has put together a strong supply chain, incorporating cutting-edge Chemistry, Manufacturing, and Controls (CMC) enhancements. Their strategy focuses on a resilient infrastructure that includes fully qualified holders of U.S. and Canadian Drug Master Files (DMF) and Certificates of Suitability (CEP) for both Active Pharmaceutical Ingredients (APIs). Such measures are essential for ensuring reliable sourcing of the components required for large-scale production of PrimeC.

In collaboration with a global Contract Development and Manufacturing Organization (CDMO), which has experience in producing PrimeC clinical batches, NeuroSense is geared up for its future commercial supply. The analytical methods that support drug product release and stability have been validated, confirming the manufacturing process can indeed meet the necessary commercial standards. Importantly, the stability data indicates that PrimeC boasts a shelf life of at least 36 months at room temperature. Coupled with the intellectual property protection granted in 2023, which extends until 2042, NeuroSense is poised to launch PrimeC effectively and securely.

CEO Alon Ben-Noon highlighted the significance of this milestone, stating, "With commercial-scale production validated and a 36-month room-temperature shelf life confirmed, PrimeC is now positioned to rapidly enter the Canadian market upon regulatory approval. This achievement, together with our patent protection through 2042, strengthens our ability to deliver PrimeC to ALS patients who urgently need new therapeutic options."

As part of its strategy to expedite market entry, NeuroSense is actively engaging with Health Canada to explore the Notice of Compliance with Conditions (NOC/c) pathway. This regulatory mechanism is designed to facilitate swift access to promising therapies for serious conditions that currently lack effective treatment options. If successful, this early market entry could not only address urgent medical needs but also generate valuable real-world data to support further global expansion. Forecasts suggest that PrimeC could achieve peak annual revenues between $100 million and $150 million in Canada, potentially solidifying NeuroSense's market presence.

NeuroSense Therapeutics has dedicated itself to addressing the significant medical needs associated with debilitating neurodegenerative diseases, such as ALS, Alzheimer's disease, and Parkinson's disease. The company's mission reflects its commitment to developing effective treatments in an area where patient options are limited. The complex nature of neurodegenerative diseases drives NeuroSense's initiative to create combined therapies targeting various pathological pathways.

As the biotechnology landscape evolves, NeuroSense's advancements bring hope not only to those affected by ALS but also to the broader realm of neurodegenerative disease treatment. With a promising product pipeline and a focused strategy, NeuroSense Therapeutics is set to make a meaningful impact in the healthcare sector and improve the lives of countless patients seeking better treatment options.

For those interested in staying updated, more information about NeuroSense and its endeavors can be found on their website and social media channels, including LinkedIn, YouTube, and X. Investors are encouraged to watch these platforms for any important information pertaining to the company’s developments and future plans.