Alector Initiates Phase 1 Trial of AL003 for the Treatment of Patients with Alzheimer’s Disease
April 01 2019 - 4:30PM
- AL003 is Alector’s second program targeting
Alzheimer’s disease and its third program in the clinic
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, a novel therapeutic approach
for the treatment of neurodegeneration, today announced the
initiation of the first-in-human Phase 1 trial for AL003, called
the INTERCEPT study. The study is initially investigating the
safety profile, pharmacodynamics and target engagement of AL003 in
healthy volunteers. AL003 is the company’s second product candidate
being developed for the treatment of patients with Alzheimer’s
disease in collaboration with its partner AbbVie.
Alector is focused on identifying and functionally repairing
genetic mutations that cause dysfunction of the brain immune system
leading to neurodegeneration. Genetic mutations in the SIGLEC 3
receptor, which is expressed on the brain’s microglia cells, were
shown to increase the risk of developing Alzheimer’s disease by
inhibiting the beneficial activity of the brain’s immune
system.
“We designed AL003 to functionally counteract the SIGLEC 3 risk
allele,” said Arnon Rosenthal, Ph.D., co-founder and chief
executive officer of Alector. “AL003, which blocks the function of
SIGLEC 3, an inhibitory receptor on the microglia, conceptually
acts in a similar manner to PD1 inhibitors in oncology, which block
the function of an inhibitory receptor on T cells. Blocking SIGLEC
3 will enable a more robust brain immune system that can better
address multiple disease-causing pathologies. and we expect this
will lead to slowing or stopping of disease progression in patients
with Alzheimer’s disease.”
The INTERCEPT study is a randomized, double-blind,
placebo-controlled, dose escalation trial that will evaluate the
safety, tolerability, pharmacokinetics, pharmacodynamics and
immunogenicity of single and multiple doses of AL003 in healthy
volunteers and patients with Alzheimer’s disease. For more
information on the trial, please visit
http://www.clinicaltrials.gov using identifier NCT03822208.
About AL003AL003 targets a sialic acid binding
Ig-like lectin 3 (SIGLEC 3) that is genetically linked to
Alzheimer’s disease. SIGLEC 3 is an inhibitory receptor expressed
primarily on cells of myeloid lineage including microglia, which
constitute the brain’s immune system. AL003 is a SIGLEC 3 blocking,
monoclonal antibody that works by blocking the function of SIGLEC 3
to increase the activity of beneficial microglia and elicit a
therapeutic benefit in Alzheimer’s disease.
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
symptoms first appear in their mid-60s. The Alzheimer’s Association
estimates that as of 2018 there are 5.7 million Americans suffering
from Alzheimer’s disease and project that number will rise to
nearly 14 million by 2050.
About Collaboration with AbbVieIn October 2017,
Alector entered into a global strategic collaboration with AbbVie
(NYSE: ABBV) a leader in neuroscience drug development, to
co-develop and commercialize therapeutics to treat Alzheimer’s 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 SIGLEC 3. 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 $205M in cash
and $20M in equity and if AbbVie exercises its option for either
program (or both programs), Alector is eligible for additional
option exercise and milestone payments totaling up to $986M.
Following AbbVie’s exercise of its option, Alector and AbbVie will
share the development costs and will split global profits equally
after marketing approval.
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 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 South
San Francisco, California. For additional information, please visit
www.alector.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains “forward-looking”
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements are based on
our beliefs and assumptions and on information currently available
to us on the date of this press release. Forward-looking statements
may involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or
achievements to be materially different from those expressed or
implied by the forward-looking statements. These statements include
but are not limited to statements regarding the Company’s plans for
and anticipated benefits and mechanism of the Company’s product
candidates, the timing and objectives of the clinical studies and
anticipated regulatory and development milestones. Except as
required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future. Important factors that could cause our
actual results to differ materially are detailed from time to time
in the reports Alector files with the Securities and Exchange
Commission, including in our annual report on Form 10-K that is
filed with the Securities and Exchange Commission (“SEC”). Copies
of reports filed with the SEC are posted on Alector’s website and
are available from Alector without charge.
Source: Alector, Inc.
Contacts
Media:1ABDan Budwick,
973-271-6085dan@1abmedia.comorInvestors:Alector,
Inc.ir@alector.com
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