“ProMIS Neurosciences announced that its PRECISE-AD Phase 1b clinical trial of PMN310—an investigational antibody therapy for Alzheimer’s disease—has surpassed its target enrollment, completing recruitment ahead of schedule. The company said this achievement positions the study to deliver its blinded 6-month biomarker assessment in the second quarter of 2026, with top-line data expected by the fourth quarter of 2026.
PRECISE-AD is a randomized, double-blind, placebo-controlled trial enrolling individuals with early Alzheimer’s disease who have biomarker evidence of amyloid pathology. Unlike many Alzheimer’s studies that rely solely on clinical outcomes, PRECISE-AD uses plasma biomarkers—such as phosphorylated tau—to measure target engagement and mechanistic effects at six and 12 months, potentially enabling earlier decision-making for future development. According to the company, completing enrollment beyond its target underscores strong patient interest in biomarker-driven trials and ProMIS’s recruitment strategy.
PMN310 is designed to selectively target toxic soluble amyloid-beta (Aβ) oligomers implicated in neuronal injury while avoiding binding to benign monomers or plaque, a profile the company believes may reduce the risk of amyloid-related imaging abnormalities (ARIA) and improve clinical benefit. The PRECISE-AD protocol evaluates safety, tolerability and changes in key biomarkers that reflect disease-related pathology.
ProMIS noted that reaching full enrollment early allows the study to maintain momentum as it transitions into the next phase of data collection and analysis. The company previously highlighted that early biomarker signals could inform dose selection and design for later-stage trials. Results from the 6-month interim analysis will be reported in an anonymized, blinded fashion to preserve study integrity.
Completion of recruitment for PRECISE-AD represents a critical milestone in ProMIS’s Alzheimer’s development program and supports its broader goal of advancing novel, precision-targeted approaches for neurodegenerative disease. The company remains on track for its planned 2026 data milestones that may guide future clinical decisions.”
