NeuroSense announced that its Phase 2b PARADIGM study of PrimeC in amyotrophic lateral sclerosis met its pre-specified primary efficacy endpoint, demonstrating a statistically significant reduction in neuron-derived tdp-43 at day 180 (p=0.0421), according to the company.
The company reported the reduction deepened and was sustained through 18 months, with continuously treated participants maintaining lower tdp-43 at day 540 (p<0.001).
NeuroSense said these biomarker findings complement previously reported clinical outcomes from PARADIGM, including statistically significant slowing of ALSFRS-R decline at 12 and 18 months (36.5%, p=0.008; 32.8%, p=0.007) and an approximately 15-month median survival benefit (HR 0.35, p=0.004).
The analysis used the NeuroDex ExoSORT method to isolate neuron-derived extracellular vesicles for measurement of neuron-derived tdp-43, and the company described favorable safety and tolerability with no new safety signals observed up to 18 months.
NeuroSense has secured FDA clearance to initiate a global Phase 3 PARAGON study and is advancing trial preparations and regulatory interactions in multiple jurisdictions, including Canada.
