Biotechnology company NeuroSense Therapeutics Ltd (NASDAQ: NRSN) announced on Wednesday that it has initiated the regulatory process to seek early commercialisation approval for its lead drug candidate, PrimeC, under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This move follows promising results from the Phase 2b ALS PARADIGM clinical trial, which showed a 36% reduction in ALS disease progression and a 43% improvement in survival rates compared to placebo.

The decision to file aligns with the recommendations from Canadian regulatory experts and is supported by both clinical and preclinical data. PrimeC, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, targets multiple mechanisms associated with ALS, including inflammation and RNA regulation.

The PARADIGM trial involved 68 participants across Canada, Italy, and Israel. Notably, 96% of participants opted for continued treatment with PrimeC after the double-blind phase. ALS, an incurable neurodegenerative disease, impacts thousands annually, with a significant disease burden projected to rise in the coming years.

In addition to Canada, NeuroSense plans to seek approval in other countries. The company is committed to addressing the substantial unmet medical needs associated with neurodegenerative diseases, leveraging a strategy focused on combined therapies targeting various disease pathways.