AL002 is a monoclonal antibody intended to enhance the activity of TREM2 and is being developed by Alector for the treatment of Alzheimer's disease in collaboration with its partner AbbVie. The data were presented today at the 12th Clinical Trials on Alzheimer's Disease (CTAD) meeting being held
The AL002 presentation at CTAD showcases the first data in humans showing that a TREM2 activating antibody engages its target and demonstrates downstream activity in the CNS. Robert Paul, M.D., Ph.D., chief medical officer of Alector, presented an abstract entitled, A Phase 1 Study of AL002 in
Summary of the clinical data of the SAD portion of the Phase 1 INVOKE clinical study presented at CTAD: 56 healthy volunteers were treated with nine escalating doses of AL002
AL002 was found to be generally safe and well-tolerated
AL002 reduced cerebrospinal fluid (CSF) soluble TREM2 (sTREM2) in a dose-dependent manner, demonstrating proof-of-target engagement in the brain
AL002 elevated a biomarker for microglia activity in the CSF, indicating proof-of-mechanism
The Phase 1b portion of the study in Alzheimer's disease patients is on-going. Alector expects to initiate the AL002 Phase 2, proof-of-concept study in 2020
'Loss of TREM2 activity has been shown through human genetics to be one of the major risk factors of developing Alzheimer's disease,' said Robert Paul, M.D., Ph.D., chief medical officer of Alector. 'AL002 is the first TREM2 agonistic antibody in clinical development for Alzheimer's disease, and we are pleased to see safety and tolerability in healthy volunteers and that AL002 is showing proof-of-target engagement and proof-of-mechanism at this early stage in development. These results together will help guide our dose selection for the Phase 2 study in Alzheimer's patients.'
About Collaboration with AbbVie
In
Under the terms of the agreement, Alector granted AbbVie an exclusive option to global development and commercialization for two programs, including TREM2. For each program, Alector is responsible for the design and execution of Phase 1 and Phase 2 studies, leveraging the Company's in-house expertise in running clinical trials in Alzheimer's disease. Following its exercise of an option for a program, AbbVie will be responsible for certain development activities and global commercialization. The terms of the agreement included an initial upfront payment of
About Alzheimer's Disease
Alzheimer's disease is a degenerative brain disease and the most common form of dementia. It is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually the ability of patients to care for themselves. In most people with Alzheimer's disease, symptoms first appear in their mid-60s.
About Alector
Alector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector is developing a broad portfolio of programs designed to functionally repair genetic mutations that cause dysfunction of the brain's immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. The Company's product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer's disease. Alector is headquartered in
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