NeuroSense Therapeutics Ltd (NASDAQ: NRSN), an Israeli late-stage clinical biotechnology company developing treatments for severe neurodegenerative diseases, announced on Wednesday that it has successfully scaled-up its production of PrimeC to commercial scale.

According to NeuroSense, this is a significant step toward bringing this potential disease-modifying Amyotrophic Lateral Sclerosis (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 aimed at positioning the company for a successful commercial launch. The company has established a manufacturing infrastructure supply chain by fully qualifying US and Canadian Drug Master File (DMF) and Certificate of Suitability (CEP) holders for both of its Active Pharmaceutical Ingredients (APIs).

Additionally, NeuroSense reported that it is partnering with a global Contract Development and Manufacturing Organisation (CDMO) that currently manufactures PrimeC clinical batches and will also support its future commercial supply.

Commercial forecasts suggest potential peak annual revenue of USD100-150m in Canada.