Cambridge, Mass. — NeuroSense Therapeutics Ltd. announced a redesigned development strategy for PrimeC, its investigational treatment for amyotrophic lateral sclerosis, aimed at shortening the path to potential regulatory approval while reducing development costs.
The plan includes three components: AI-enabled analysis of PrimeC’s formulation, a head-to-head clinical study against edaravone and a streamlined pivotal development pathway. The company is also pursuing a parallel regulatory submission in Canada.
NeuroSense said the strategy builds on data from its Phase 2b PARADIGM study, which showed effects on functional decline, changes in extracellular vesicle-associated TDP-43 and other disease-related biomarkers, as well as encouraging long-term survival results.
The company has already received FDA clearance to begin its pivotal Phase 3 PARAGON trial.
PrimeC is an extended-release fixed-dose combination designed to synchronize the pharmacokinetic profiles of its two active components. NeuroSense said a completed pharmacokinetic study showed that PrimeC produced a synchronized exposure profile that was not replicated when the individual components were given together.
The company is now using AI-enabled modeling to further characterize that difference and assess its consistency across patients. NeuroSense said the work could also support additional patent protection and help differentiate PrimeC from co-administration of its individual components.
NeuroSense also plans an active-comparator study evaluating PrimeC directly against edaravone, an established ALS therapy. The company said a head-to-head study could provide additional evidence of PrimeC’s clinical and commercial differentiation.
For its pivotal program, NeuroSense is evaluating a smaller and shorter Phase 3 PARAGON study that would enroll patients earlier in the course of their disease and potentially support an earlier regulatory submission.
Any revised Phase 3 design would require alignment with the FDA. NeuroSense said it plans to discuss whether existing data could support full approval or an accelerated approval pathway, potentially followed by an additional post-approval study.
In Canada, NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC. The company continues to target December 2026 for the filing.
“One of the hardest constraints in ALS is not scientific – it is that the standard development path takes longer than patients have,” said Alon Ben-Noon, Co-Founder and CEO of NeuroSense. “We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer. It is faster, it costs less, and it produces a stronger package – pharmacology, comparative clinical context, and a pivotal dataset – than the single-trial approach would have.”
