Alector Announces Initiation of Phase 1b Study of AL003 in Alzheimer’s Disease Patients
January 28 2020 - 8:30AM
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today announced the dosing of
the first Alzheimer’s disease patient in the Phase 1b portion of
the INTERCEPT clinical study of AL003. AL003 is Alector’s second
clinical-stage program targeting Alzheimer’s disease and is being
developed in collaboration with its partner, AbbVie.
“We have developed AL003 to block the inhibitory function of
SIGLEC 3, an immune receptor linked to Alzheimer’s disease. AL003
is intended to allow the brain’s immune system to simultaneously
address multiple parallel pathologies involved in the progression
of Alzheimer’s disease,” said Arnon Rosenthal, Ph.D., chief
executive officer.
The Phase 1b portion of the INTERCEPT clinical study will assess
the safety of multiple doses of AL003 in approximately 12 patients
with mild to moderate Alzheimer’s disease. The study’s primary
endpoints are safety and tolerability and the secondary endpoints
are pharmacokinetics (PK), pharmacodynamics (PD), target engagement
and target-specific biomarker changes related to AL003 in plasma
and in cerebrospinal fluid (CSF) in Alzheimer’s disease
patients.
“We evaluated the pharmacokinetics and pharmacodynamics of AL003
and found tolerable doses in a placebo-controlled, single-ascending
dose escalation study in healthy volunteers. We are encouraged by
the long-lasting target engagement that AL003 displayed with a
blood-based biomarker even at low doses in these healthy
volunteers. We look forward to evaluating AL003 in Alzheimer’s
disease patients in the Phase 1b study,” said Robert Paul, M.D.,
Ph.D. chief medical officer.
About AL003AL003 targets sialic acid binding
Ig-like lectin 3 (SIGLEC 3) that is a genetic risk factor for
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 monoclonal
antibody that works by blocking the function of SIGLEC 3 to
increase the activity of microglia and that is intended to treat
Alzheimer’s disease.
About Alzheimer’s DiseaseAlzheimer’s disease is
a degenerative brain disease and the most common cause 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 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, AL003 and AL002 (a TREM2 targeting monoclonal
antibody). 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 Company’s
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 (“SEC”), including Alector’s most recent
Annual Report on Form 10-K filed with the SEC on March 26, 2019,
and Quarterly Report on Form 10-Q filed with the SEC on November
12, 2019. 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
AbbVie (NYSE:ABBV)
Historical Stock Chart
From Jun 2024 to Jul 2024
AbbVie (NYSE:ABBV)
Historical Stock Chart
From Jul 2023 to Jul 2024