NeuroSense Says Phase 2b ALS Study Meets Primary Endpoint

(RTTNews) - NeuroSense Therapeutics Ltd. (NRSN) on Monday said its Phase 2b PARADIGM study of PrimeC in patients with amyotrophic lateral sclerosis (ALS) met its primary efficacy endpoint, demonstrating a statistically significant reduction in TDP-43 levels compared with placebo.

The company said the trial is the first randomized, double-blind, placebo-controlled study to show a treatment-related reduction in TDP-43, a key pathological hallmark of ALS, in people living with the disease.

NeuroSense said the effect was sustained and deepened throughout the 18-month study, with patients receiving continuous PrimeC treatment maintaining lower TDP-43 levels than those in the placebo group at Day 540.

The company has received U.S. Food and Drug Administration clearance to begin its Phase 3 PARAGON study and is continuing regulatory discussions in multiple jurisdictions, including Canada.

NeuroSense Shares are currently trading at $0.8001, up 5.64%.