Alector, Inc. Announces First Participant Dosed in Phase 2 Study Evaluating AL002 in Individuals with Early Alzheimer’s Disease
January 25, 2021 at 07:00 pm IST
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Alector, Inc. announced that the first participant has been dosed in INVOKE-2, a Phase 2 clinical study evaluating the efficacy and safety of AL002 in slowing disease progression in
individuals with early Alzheimer’s disease. AL002 is an investigational, humanized monoclonal antibody that targets triggering receptor expressed on myeloid cells 2 (TREM2), a transmembrane receptor protein that is expressed on a subset of innate immune cells and selectively on microglia, which serve as the immune cells in the brain. The AL002 clinical program is being developed in collaboration with AbbVie. The role of TREM2 in Alzheimer’s disease was first discovered through large scale genome-wide association studies where it has been shown to have one of the most important genetic links to sporadic Alzheimer’s disease. Research suggests that reduction of TREM2 functionality may lead to Alzheimer's disease and other forms of dementia. Increasing TREM2 activity in the brain may prove to be an effective therapeutic approach by activating the brain’s immune system to target multiple pathologies that are present in Alzheimer’s disease, rather than focusing on a single pathology. INVOKE-2 is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2 study that will enroll approximately 265 participants with early Alzheimer’s disease at up to 90 sites globally. The primary endpoint of the Phase 2 study is to measure disease progression utilizing the Clinical Dementia Rating Sum Boxes (CDR-SB). The CDR-SB is a validated instrument that assess both cognitive and functional domains and is used to assess (score) the severity of Alzheimer’s disease. The study will also employ multiple fluid and imaging biomarkers, and will assess several secondary clinical, pharmacokinetic and pharmacodynamic endpoints, as well as the safety of treatment with AL002.
Alector, Inc. is a clinical-stage biotechnology company. The Company is focused on immuno-neurology, a novel therapeutic approach for the treatment of neurodegeneration diseases. The Company is engaged in developing therapies designed to counteract these pathologies simultaneously by restoring healthy immune function to the brain. Its research and drug discovery platform leverages human genetic datasets, advanced tools in bioinformatics and imaging, and insights in neurodegeneration and immunology to identify immune system. Its product candidates: latozinemab (AL001), AL002, and AL101, are in clinical development. Its immune-neurology product candidates are supported by biomarkers and seek to treat indications, including Alzheimerâs disease and genetically defined frontotemporal dementia patient populations. Its first product candidate, latozinemab, is a human recombinant monoclonal antibody that increases the levels of progranulin (PGRN) in the brains of FTD-GRN patients.