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
2023年9月7日 - 8:00PM
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today announced that it has
completed enrollment in INVOKE-2, the Phase 2 clinical trial of
AL002. INVOKE-2 is evaluating the safety and efficacy of AL002 in
slowing disease progression in individuals with early Alzheimer’s
disease (AD). Data from the trial are expected in the fourth
quarter of 2024. AL002 is a novel investigational humanized
monoclonal antibody (mAb) that binds to triggering receptor
expressed on myeloid cells 2 (TREM2). AL002 is the most advanced
TREM2 activating product candidate in clinical trials and is being
developed in collaboration with AbbVie.
“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 Arnon Rosenthal, Ph.D., Chief Executive
Officer of Alector. “We are also encouraged to see that nearly all
eligible participants are rolling over into the long-term extension
of the INVOKE-2 trial, which will enable us to better understand
the long-term effects of this potential therapeutic. Notably,
results from a Phase 1 clinical trial of AL002 in healthy
volunteers demonstrated both dose dependent target engagement and
activation of microglia. We look forward to an INVOKE-2 data
readout in the fourth quarter of 2024, which will inform a
potential pivotal Phase 3 clinical development program for AL002
that enables registration.”
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.
Additional information about INVOKE-2 (NCT04592874) may be found
at ClinicalTrials.gov.
At the 2023 Alzheimer’s Association International Conference
(AAIC) in July, Alector presented an update on INVOKE-2. The
presentation highlighted previously reported treatment-emergent MRI
findings observed in INVOKE-2 that resemble amyloid-related imaging
abnormalities (ARIA). It is unknown whether the biological
mechanism(s) causing these MRI changes are the same as that
associated with the ARIA that has been described with anti-amyloid
beta antibodies.
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.
About AL002AL002 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 AbbVieIn October 2017,
Alector entered into a global strategic collaboration with AbbVie
(NYSE: ABBV), to co-develop and commercialize therapeutics to treat
Alzheimer’s disease and other neurodegenerative diseases. Under the
terms of the agreement, Alector granted AbbVie an exclusive option
to global development and commercialization for the AL002 TREM2
program. If AbbVie exercises its option for the program, Alector
would be eligible for additional option exercise and milestone
payments totaling up to $487.5M. Both companies will share the
development costs and will split global profits equally after
marketing approval.
About Alzheimer’s DiseaseAlzheimer’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
About AlectorAlector 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 has discovered and is developing a broad
portfolio of innate immune system programs, designed to
functionally repair genetic mutations that cause dysfunction of the
brain’s immune system and enable rejuvenated immune cells to
counteract emerging brain pathologies. Alector’s immuno-neurology
product candidates are supported by biomarkers and target
genetically defined patient populations in frontotemporal dementia
and Alzheimer’s disease. Alector is headquartered in South San
Francisco, California. For additional information, please visit
www.alector.com.
Forward-Looking StatementsThis 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 August 3, 2023, with the Securities and
Exchange Commission (“SEC”), as well as the other documents Alector
files from time to time with the SEC. These documents contain and
identify important factors that could cause the actual results for
Alector to differ materially from those contained in Alector’s
forward-looking statements. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Alector specifically disclaims any obligation to update any
forward-looking statement, except as required by law.
Alector Contacts:
Alector Katie Hogan 202-549-0557katie.hogan@alector.com
1AB (media)Dan Budwick973-271-6085 dan@1abmedia.com
Argot Partners (investors)Laura Perry Argot
Partners212-600-1902alector@argotpartners.com
1 2023 Alzheimer’s Disease Facts and Figures
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