Alector Announces First Participant Dosed in Phase 2 Study Evaluating AL002 in Individuals with Early Alzheimer’s Disease
January 25 2021 - 7:30AM
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today 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.
“Loss of TREM2 activity has been shown through human genetics to
be one of the notable risk factors for developing Alzheimer’s
disease,” said Robert Paul, M.D., Ph.D., chief medical officer
of Alector. “AL002 is a first-in-class TREM2 targeting
antibody in Phase 2 clinical development for Alzheimer’s disease.
By targeting this receptor, we believe it may be possible to slow
the progression of this disease. Our ability to move quickly into a
Phase 2 study is based on compelling preclinical and Phase 1 data
showing that AL002 engages TREM2 on microglia cells in the brain,
resulting in increased microglial activity. We look forward to
efficiently enrolling the Phase 2 study to better understand the
potential clinical benefits of AL002.”
“Alzheimer’s is a devastating disease that robs a person of
their identity, and a family of their loved one. We are hopeful
that AL002 may one day be a treatment option for the millions of
people diagnosed with this disease,” said Michael Gold, M.D., vice
president, Development Neurosciences, AbbVie. “We are pleased that
the study was initiated rapidly and look forward to data from the
Phase 2 study that will inform a potential pivotal clinical
development program for AL002.”
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.
To learn more about the Phase 2 study, please visit
https://clinicaltrials.gov/.
About AL002AL002 is an investigational
humanized monoclonal antibody that targets triggering receptor
expressed on myeloid cells 2 (TREM2) with the most important
genetic links to 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 optimizing TREM2 signaling to improve
cell survival and proliferation, and activity of microglia.
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 two programs,
including TREM2. Following AbbVie’s exercise of its option for
either program (or both), Alector is eligible for additional option
exercise and milestone payments totaling up to $986M. 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 2020, there are 5.8 million Americans aged 65 and older
living with Alzheimer’s disease, and projects that number will rise
to nearly 14 million by
2050.About AlectorAlector is a clinical
stage biotechnology company pioneering immuno-neurology, a novel
therapeutic approach for the treatment of neurodegenerative
diseases. The Company 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 the rejuvenated immune cells to counteract
emerging brain pathologies. Immuno-neurology targets immune
dysfunction as a root cause of multiple pathologies that are
drivers of degenerative brain disorders. The Company’s
immuno-neurology product candidates are supported by biomarkers and
target genetically defined patient populations in frontotemporal
dementia and Alzheimer’s disease. This scientific approach is also
the basis for the Company’s immuno-oncology
programs. 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. Such statements
are subject to numerous important factors, risks and uncertainties
that may cause actual events or results to differ materially from
current expectations and beliefs, including but not limited to
risks and uncertainties related to the Company’s plans for and
anticipated benefits and mechanism of the Company’s product
candidates, the timing and objectives of the Company’s clinical
studies and anticipated regulatory and development milestones, and
Alector and its business as set forth in Alector’s Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission (the
“SEC”) on November 10, 2020, 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.
Contacts:
Media Erica JeffersonVice President, Communications and Public
AffairsAlector, Inc.301-928-4650erica.jefferson@alector.com
1AB Dan Budwick973-271-6085 dan@1abmedia.comor
Investors: Alector, Inc. ir@alector.com
AbbVie (NYSE:ABBV)
Historical Stock Chart
From Apr 2024 to May 2024
AbbVie (NYSE:ABBV)
Historical Stock Chart
From May 2023 to May 2024