The PARADIGM study utilized the NeuroDex ExoSORT procedure to isolate neuron-derived extracellular vesicles, allowing researchers to measure TDP-43 levels specifically within the central nervous system. At the 180-day mark, participants receiving PrimeC showed a significant decrease in the protein compared to those in the placebo group, with the effect remaining consistent through the 540-day observation period.

Beyond biomarker reduction, the trial reported a 32.8% slowing of ALSFRS-R decline at 18 months and a median survival benefit of approximately 15 months. Alon Ben-Noon, CEO of NeuroSense, noted that while TDP-43 has long been recognized as the pathological signature of the disease, effectively reducing it in humans had previously remained elusive. The company is now preparing to transition these results into a global Phase 3 PARAGON study, having already secured clearance from the FDA to move forward with further clinical evaluation.