Safety and Efficacy of PrimeC in Amyotrophic Lateral Sclerosis

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

Corresponding Author: Jeremy M. Shefner, MD, PhD, Department of Neurology, Barrow Neurological Institute, 2910 N Third Ave, Phoenix, AZ 85013 (jeremy.shefner@commonspirit.org).

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