NeuroSense reports Phase 2b ALS endpoint success

• NeuroSense Therapeutics (NASDAQ:NRSN) said its Phase 2b PARADIGM study of PrimeC met its primary endpoint in ALS.
• The study showed reduced neuron-derived TDP-43 levels and slowed ALS progression versus placebo.
• The company said it has FDA clearance to begin a global Phase 3 PARAGON trial.

NeuroSense Therapeutics (NASDAQ:NRSN) reported that its Phase 2b PARADIGM study of PrimeC in amyotrophic lateral sclerosis met its primary endpoint, showing a statistically significant reduction in neuron-derived TDP-43 compared with placebo at Day 180.

The company said the treatment effect strengthened over time, with greater reductions observed at Day 540.

NeuroSense also reported statistically significant slowing of ALS Functional Rating Scale-Revised (ALSFRS-R) decline at 12 and 18 months, with reductions of 36.5% and 32.8% versus placebo.

The company said the study showed an estimated median survival benefit of about 15 months, based on a hazard ratio of 0.35.

NeuroSense said PrimeC demonstrated multi-biomarker target engagement along with a favorable safety profile throughout the study period.

The company also confirmed it has FDA clearance to initiate its global Phase 3 PARAGON trial in ALS.