NeuroSense Therapeutics said Monday, November 2, that it now plans to submit its Canadian marketing application for the experimental ALS treatment PrimeC in March 2027, moving the target from December 2026 to add new biomarker data.
The company announcement said the expanded submission will include a new analysis of neurofilament light chain, or NfL, alongside results and additional unpublished data from its Phase 2b PARADIGM trial. Further statistical work on the new findings remains underway.
NeuroSense said Health Canada had confirmed it had no concerns with the revised filing schedule. That statement concerns timing: it is not an approval of PrimeC, an acceptance of an application for review or a finding that the treatment is effective.
The planned New Drug Submission would be PrimeC’s first marketing application in any jurisdiction. The company said it had completed the pre-submission process and aligned with Health Canada on the proposed content and structure of the package. An application still has to be filed and reviewed.
According to NeuroSense, participants treated with PrimeC showed a greater reduction in NfL than those receiving placebo in the new analysis, with a more pronounced effect among participants with higher baseline functionality. The release did not give numerical effect sizes or statistical significance values for those findings. They should not be read as a new, independently established clinical benefit.
NfL is a measure of neuronal injury used in ALS research, the company said. Chief Executive Alon Ben-Noon said adding the analysis is intended to give regulators a broader evidence base for evaluating the treatment’s potential.
NeuroSense cited an approximately 300-calendar-day standard Health Canada review target after acceptance of a New Drug Submission for review. That is not a promised decision date, and the company cautioned that submission, acceptance, review timing and approval remain uncertain.
PrimeC is an investigational extended-release oral formulation combining ciprofloxacin and celecoxib. Although those component drugs are FDA-approved, that does not mean the PrimeC combination is approved for ALS.
The company also said it is preparing for its FDA-cleared U.S. Phase 3 PARAGON trial and discussing possible Canadian commercialization partnerships. Clearance to begin a clinical trial is separate from approval to market a medicine, and no Canadian partner agreement was announced Monday.
JBizNews Desk | New York
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