NeuroSense Announces Favorable Phase 2b ALS Trial Results Meeting Primary Endpoint

NeuroSense Therapeutics Ltd. (NRSN) announced that its Phase 2b PARADIGM trial of PrimeC in ALS patients met the primary efficacy endpoint, achieving a statistically significant reduction in TDP‑43 levels versus placebo.

The company emphasized that this trial represents the first randomized, double‑blind, placebo‑controlled study to demonstrate a treatment‑related reduction in TDP‑43, a central pathological marker of ALS, among patients with the disease.

NeuroSense reported that the reduction in TDP‑43 was sustained and further deepened over the 18‑month study period, with patients on continuous PrimeC therapy maintaining lower TDP‑43 levels than the placebo group at day 540.

The company has obtained U.S. Food and Drug Administration clearance to initiate its Phase 3 PARAGON study and is actively engaged in regulatory discussions across multiple jurisdictions, including Canada.

Source link