TDP-43 (PARADIGM)

June 29, 2026: NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) reported that its randomized, double-blind, placebo-controlled Phase 2b PARADIGM trial of PrimeC in amyotrophic lateral sclerosis (ALS) met its pre-specified primary efficacy endpoint, showing a statistically significant reduction in TDP-43 vs placebo at Day 180 (p=0.0421). Using NeuroDex’s ExoSORT procedure to isolate neuron-derived extracellular vesicles, the company said the TDP-43 reduction was sustained and deepened through 18 months, with continuously treated participants maintaining lower TDP-43 levels than placebo at Day 540 (p<0.001).

The update cites previously reported PARADIGM outcomes: slower ALSFRS-R decline at 12 and 18 months (36.5%, p=0.008; 32.8%, p=0.007), an approximately 15-month median survival benefit (HR 0.35, p=0.004), consistent modulation of biomarkers (including iron-regulatory and ALS-associated microRNAs), and a favorable safety/tolerability profile with no new safety signals over up to 18 months.

NeuroSense also stated it has FDA clearance to initiate a global pivotal Phase 3 PARAGON study in ALS (expected ~300 participants) and is advancing preparations and regulatory interactions in multiple jurisdictions, including Canada.