PrimeC demonstrated comparable safety to placebo and showed slowed functional decline, reduced ALS-related complications, and modulation of iron-regulatory and microRNA biomarkers in adults with ALS over 18 months of treatment.

Question Is PrimeC safe and well tolerated in people with amyotrophic lateral sclerosis (ALS), and does it demonstrate clinical and biomarker activity?

Findings In this randomized clinical trial, PrimeC demonstrated a safety profile comparable to placebo over 18 months. Continuous treatment was associated with slower functional decline, reduced risk of ALS-related complications, and increased probability of overall survival, alongside significant modulation of iron-regulatory and microRNA biomarkers.

Meaning These findings reinforce the safety and treatment effect in conjunction with biologic activity of PrimeC treatment and support confirmatory evaluation in phase 3 trial as a potential disease-modifying therapy for ALS.