NeuroSense Therapeutics (NASDAQ: NRSN) met the primary efficacy endpoint in its Phase 2b PARADIGM trial. The study evaluated the ALS drug candidate PrimeC. Results showed a statistically significant reduction in TDP-43 levels. This pathological protein is associated with over 97% of ALS cases.
The findings represent the first treatment-related reduction of this biomarker in a randomized, placebo-controlled trial. Analysis utilized NeuroDex's ExoSORT platform to measure brain-specific proteins. This blood-based test isolates neuron-derived particles to identify disease markers.
PrimeC also demonstrated a slowing of disease progression. Patients treated with the drug candidate experienced a survival benefit.
NeuroSense is now advancing to a global Phase 3 pivotal study named PARAGON. The FDA has already granted clearance to initiate this trial.