NEW YORK – Alector on Thursday said it has finished enrolling a Phase II trial of AL002, an investigational drug designed to slow disease progression for patients with early Alzheimer's disease.
AL002, which Alector is developing with AbbVie, is a monoclonal antibody that targets triggering receptor expressed on myeloid cells 2 (TREM2). This transmembrane receptor is expressed on a subset of immune cells, and its reduced functionality has been linked with Alzheimer's. AL002 is designed to activate TREM2 signaling to improve cell survival and microglia activity.
The fully enrolled INVOKE-2 trial is a randomized, double-blind, placebo-controlled, and dose-ranging study, in which Alector is assessing the safety and efficacy of AL002. Patients with early Alzheimer's are enrolled at multiple study sites across 11 countries and will receive either intravenously administered AL002 or a placebo every four weeks for at least 48 weeks.
Alector will follow patients to gauge how their Alzheimer's progresses as measured by the Clinical Dementia Rating-Sum of Boxes scoring system. Investigators will also analyze changes in patients' brain volume, track their amyloid and tau biomarkers, and assess clinical and functional outcomes.
"We look forward to an INVOKE-2 data readout in the fourth quarter of 2024, which will inform a potential pivotal Phase III clinical development program for AL002 that enables registration," Alector CEO Arnon Rosenthal said in a statement. The company believes AL002 may have potential as a single-agent Alzheimer's treatment and in combination with other anti-amyloid therapies.
Under the terms of a 2017 agreement, Alector granted AbbVie an exclusive option to develop and commercialize AL002 globally. If AbbVie exercises that option, Alector will be eligible for up to $487.5 million in option exercise and milestone payments. Both companies will share development costs and split global profits equally.