Alector Announces Phase 1 Data on AL002 at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting
December 06 2019 - 4:30PM
Alector, Inc. (Nasdaq: ALEC), a clinical stage biotechnology
company pioneering immuno-neurology, today reported safety and
biomarker data from the single ascending dose (SAD) phase of the
INVOKE Phase1 study of its product candidate, AL002, in healthy
volunteers. 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 December 4-6 in
San Diego, California.
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 Healthy Volunteers and
Patients With Mild-To-Moderate Alzheimer’s Disease during an oral
communications session. The INVOKE clinical study is a
first-in-human study in healthy adults and in patients with mild to
moderate Alzheimer's disease, designed to assess the safety
(including immunogenicity) and tolerability, pharmacokinetics (PK),
and pharmacodynamics (PD) of AL002. The data reported today are
from the study's SAD phase in 56 healthy adults, who were enrolled
into nine escalating dose cohorts.
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 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
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. 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 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 2018, there are 5.7 million
Americans suffering from 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. 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 quarterly report on
Form 10-Q 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.
ContactsMedia:1ABDan Budwick,
973-271-6085dan@1abmedia.com Investors:Alector,
Inc.ir@alector.com
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