NeuroSense Therapeutics is set to meet with the U.S. Food and Drug Administration (FDA) on November 6, 2024, to discuss the Phase 3 clinical trial design for PrimeC, a drug candidate for Amyotrophic Lateral Sclerosis (ALS). The goal is to align the trial with requirements for a New Drug Application (NDA) submission, potentially expediting the drug's approval process.
FDA Meeting Focus
The Type C meeting with the FDA will center on finalizing the Phase 3 trial design for PrimeC. NeuroSense aims to ensure that its regulatory strategy is in sync with the FDA's expectations, paving the way for a smooth NDA submission, assuming the trial yields positive results. An update on the meeting's outcomes is expected approximately one month after the meeting, following receipt of the meeting minutes.
PrimeC's Potential
PrimeC, NeuroSense's primary drug candidate, has shown promise in earlier clinical trials. These trials indicated a statistically significant reduction in disease progression, as well as improvements in clinical and biological markers associated with ALS. Given the urgent need for effective ALS treatments, NeuroSense is positioning PrimeC as a potential breakthrough therapy.
Canadian Regulatory Pathway
In parallel with its U.S. strategy, NeuroSense is also preparing to submit its regulatory dossier to Health Canada in the second quarter of 2025. The company anticipates a regulatory decision regarding the commercialization of PrimeC in Canada by the first quarter of 2026. NeuroSense estimates the Canadian market opportunity for PrimeC to be between $100 million and $150 million in annual revenue.
Clinical Data Supporting PrimeC
Recent clinical findings have demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo. These results underscore PrimeC's potential as a disease-modifying drug for ALS. The data comes from the PARADIGM study, a Phase 2b trial (NCT05357950) that included 68 participants with ALS in Canada, Italy, and Israel. 96% of participants completing the 6-month double-blind portion of the trial opted to continue treatment with PrimeC through a 12-month open-label extension.
About PrimeC
PrimeC is an extended-release oral formulation combining ciprofloxacin and celecoxib. It is designed to target key mechanisms of ALS, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. PrimeC has received Orphan Drug Designation from both the FDA and the European Medicines Agency.
ALS Context
ALS is a neurodegenerative disease leading to paralysis and death within 2-5 years of diagnosis. Over 5,000 people are diagnosed with ALS annually in the U.S., resulting in an annual disease burden of $1 billion. The number of people living with ALS is projected to increase by 24% by 2040 in the U.S. and EU.
