Alzheon announced a peer-reviewed publication presenting integrated analyses of Phase 3 APOLLOE4 and Phase 2 data that, according to the company, showed early and sustained reductions in plasma p-tau217 and the p-tau217/Aβ42 ratio in APOE4 carriers with early Alzheimer’s disease.
The company claims those biomarker changes correlated with less cognitive and functional decline on measures including ADAS-Cog13 and CDR-SB and with reduced hippocampal atrophy and preserved cortical thickness, and that plasma neurofilament light chain remained lower versus placebo at Week 78 in mild cognitive impairment patients and correlated with cognitive improvement.
The APOLLOE4 trial was a 78-week, double-blind randomized study with a long-term extension that ended in January 2026, and Phase 2 extension data cover roughly four years.
Alzheon claims valiltramiprosate/ALZ-801 maintained a favorable safety profile with no increase in ARIA-E versus placebo and no symptomatic ARIA.
Valiltramiprosate is in Phase 3 development and received Fast Track designation from the U.S. Food and Drug Administration in 2017, and the company plans further Phase 3 work in APOE4 carriers.
