NeuroSense PrimeC Phase 2b ALS study meets primary endpoint
NeuroSense Therapeutics announced that its Phase 2b PARADIGM study of PrimeC for amyotrophic lateral sclerosis (ALS) successfully met its primary efficacy endpoint. The study demonstrated a statistically significant reduction in TDP-43 levels compared to placebo, marking the first time a randomized, double-blind, placebo-controlled trial has shown a treatment-associated reduction of this key pathological hallmark in ALS patients. These findings, combined with previously reported clinical outcomes including slowed disease progression, a significant survival benefit, and consistent biomarker modulation, support PrimeC's potential as a disease-modifying therapy. The company has secured FDA clearance for its global Phase 3 PARAGON study and is advancing trial preparations.
Key Highlights
- PrimeC Phase 2b PARADIGM study met primary endpoint with statistically significant reduction in TDP-43 (p=0.0421).
- TDP-43 reduction was sustained and deepened over 18 months, with lower levels at Day 540 (p<0.001).
- Statistically significant slowing of ALSFRS-R decline: 36.5% at 12 months (p=0.008) and 32.8% at 18 months (p=0.007).
- Demonstrated a statistically significant ~15-month median survival benefit (HR 0.35, p=0.004).
- PrimeC showed a favorable safety and tolerability profile over up to 18 months of treatment.
- FDA clearance secured to initiate global Phase 3 (PARAGON) study for PrimeC in ALS.
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