NeuroSense Therapeutics (NASDAQ:NRSN) reported on Monday the successful completion of a safety analysis for its Phase 2 NST-AD-001 study, a critical step in the company's efforts to repurpose its lead ALS candidate, PrimeC, for the treatment of Alzheimer’s disease.
The randomized, double-blind, placebo-controlled "RoAD" study found a favorable tolerability profile among participants, with no serious adverse events (SAEs) or unexpected safety signals identified during the treatment period.
The study serves as an exploratory proof-of-concept, designed primarily to evaluate the safety and biological activity of PrimeC—a fixed-dose combination of the FDA-approved drugs ciprofloxacin and celecoxib.
While clinical outcome measures in this trial are descriptive rather than purely quantitative, the absence of safety concerns allows the company to move forward with a full analysis of the trial's secondary endpoints.
NeuroSense is now shifting its focus to the integration of clinical observations with biomarker data.
This comprehensive review aims to identify "target engagement," or evidence that the drug is successfully reaching and affecting the biological pathways associated with Alzheimer’s pathology, such as neuroinflammation and iron accumulation.
The company expects to release full clinical and biomarker results in the first quarter of 2026.