NeuroSense reported that results from its PARADIGM Phase 2b randomized, double-blind, placebo-controlled trial of PrimeC in amyotrophic lateral sclerosis were published in JAMA Neurology, following a 6-month blinded period and a 12-month open-label extension. Continuous PrimeC treatment was associated with a 7.92-point ALSFRS-R advantage at 18 months versus placebo, and a 64% relative reduction in risk of ALS-related complications with early initiation. The publication also reported modulation of ALS-related microRNAs and iron-regulatory biomarkers, including downregulation of miR-199a-3p and stabilization of ferritin. NeuroSense said the findings supported advancement of PrimeC to a confirmatory Phase 3 trial in ALS, and that the Phase 3 trial has received FDA clearance to proceed.
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