Alector Announces Completion of Enrollment in the INVOKE-2 Phase 2 Clinical Trial of AL002, a TREM2 Monoclonal Antibody, in Individuals With Early Alzheimer’s Disease
“The successful completion of enrollment in the INVOKE-2 Phase 2 trial marks a significant milestone in the ongoing development of AL002, bringing us one step closer to potentially introducing this prospective new class of therapeutics to individuals impacted by Alzheimer's disease,” said
INVOKE-2 is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2 clinical trial being conducted at multiple sites across 11 countries. Participants with early AD are randomized to receive AL002 or placebo administered intravenously every four weeks. The trial utilizes a common close design with up to 96 weeks of randomized treatment, and all participants remain on their assigned regimen until the last participant completes 48 weeks of treatment. This design provides the opportunity to capture more observations for the primary analysis. The primary endpoint is disease progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR®-SB). The CDR-SB, which is used to assess (score) the severity of AD, is a validated instrument that assesses both cognitive and functional domains and is the accepted efficacy endpoint for FDA. The trial also employs other multiple clinical and functional outcome assessments. Additionally, the trial includes cerebrospinal fluid (CSF) and plasma biomarkers assessing microglial activation and Alzheimer’s pathophysiology, as well as brain magnetic resonance imaging (MRI) and amyloid beta and tau positron emission tomography (PET) imaging.
At the 2023 Alzheimer’s
It is hypothesized that AL002 may provide potential benefit alone or in combination with anti-amyloid beta antibodies by potentially harnessing the broader beneficial effects of microglia. Microglia activation may not only enhance the clearance of misfolded proteins that accumulate and form amyloid plaques but may also perform other supportive microglia functions, including maintenance of neuronal and synaptic health, and warrants further investigation.
AL002 is an investigational humanized monoclonal antibody that targets triggering receptor expressed on myeloid cells 2 (TREM2), an important genetic risk factor for sporadic Alzheimer’s disease. TREM2 is a transmembrane receptor expressed on a subset of innate immune cells and selectively on microglia, which constitute the brain’s immune system. Reduction of TREM2 functionality may lead to Alzheimer's disease and other forms of dementia. AL002 counteracts this decreased functionality by activating TREM2 signaling to improve cell survival and proliferation as well as microglia activity. The clinical benefits of this activity are unknown and are the focus of the AL002 clinical trials.
Collaboration with AbbVie
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. The Alzheimer’s Association estimates that as of 2023, there are 6.7 million Americans aged 65 and older living with Alzheimer’s disease, and projects that number will rise to nearly 14 million by 2060.1
Alector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our product candidates, planned and ongoing preclinical studies and clinical trials, expected milestones, including the timing of data from our INVOKE-2 trial, and expectations of our collaborations. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Quarterly Report on Form 10-Q filed on
Argot Partners (investors)
Source: Alector, Inc.