LM11A-31 for mild to moderate Alzheimer disease
phase 2Develop a disease-modifying therapy for mild to moderate Alzheimer disease by modulating p75 neurotrophin receptor signaling pathways implicated in neurodegeneration, synaptic loss, and disease progression.
First-in-class oral small molecule targeting the p75 neurotrophin receptor; evaluated in a 26-week randomized, placebo-controlled, double-blind Phase 2a trial with placebo, 200 mg LM11A-31, and 400 mg LM11A-31 arms administered twice daily by oral capsules.
Completed a randomized placebo-controlled Phase 2a trial in 242 participants with mild to moderate Alzheimer disease; trial met its primary safety and tolerability endpoint.
The Phase 2a study reported significant drug-placebo differences in prespecified secondary and exploratory domains including structural MRI, FDG-PET, and cerebrospinal fluid biomarkers, consistent with slowed progression of pathophysiological features of Alzheimer disease. No significant active-treatment effect was observed on cognitive tests.