Acumen Announces First Patient Dosed in a Phase 1 Clinical Trial of ACU193, a Monoclonal Antibody that Selectively Targets Toxic Aβ Oligomers for the Treatment of Early Alzheimer’s Disease
October 07 2021 - 8:00AM
Acumen Pharmaceuticals, Inc., a clinical stage biopharmaceutical
company focused on the development of novel targeted therapeutics
for Alzheimer’s disease (AD), today announced dosing of the first
patient in INTERCEPT-AD, the Phase 1 placebo-controlled, single-
and multiple-dose clinical trial of ACU193, a monoclonal antibody
that selectively targets toxic amyloid-beta oligomers (AβOs) for
the treatment of early AD.
“We are very pleased to report this first clinical development
milestone for ACU193,” said Daniel O’Connell, President and CEO of
Acumen. “We are encouraged by recent momentum and the breadth of
scientific innovation that is being applied to Alzheimer’s
research. We believe ACU193 has distinct potential to address the
continued unmet medical needs of people living with Alzheimer’s
disease.”
ACU193 is a monoclonal antibody (mAb) discovered and developed
based on its selectivity for AβOs, which Acumen believes are the
most toxic and pathogenic form of Aβ, relative to Aβ monomers and
amyloid plaques. AβOs have been observed to be potent neurotoxins
that bind to neurons, inhibit synaptic function and induce
neurodegeneration. By selectively targeting toxic AβOs, ACU193 aims
to directly address what a growing body of evidence indicates is a
primary underlying cause of the neurodegenerative process in
AD.
“We are all very excited about evaluating ACU193 in the
INTERCEPT-AD trial,” said Eric Siemers MD, Chief Medical Officer
for Acumen. “Our goal for this Phase 1 clinical trial is to
establish proof of mechanism for ACU193, including overall safety
and tolerability, pharmacokinetics and target engagement. We have
also incorporated standard clinical outcomes for AD as well as
exploratory assessments. Based on ACU193’s unique mechanism of
action, we believe it has the potential for improved efficacy and
for improved safety compared to other monoclonal antibodies in
development.”
About INTERCEPT-AD Approximately 62 individuals
with early AD (mild cognitive impairment or mild dementia due to
AD) are expected to be randomized into this double-blind,
placebo-controlled, first-in-human study of ACU193. INTERCEPT-AD is
designed to establish safety and proof of mechanism. It consists of
single-ascending-dose (SAD) and multiple-ascending-dose (MAD)
cohorts and is designed to evaluate the safety, tolerability,
pharmacokinetics (PK), and target engagement of intravenous doses
of ACU193. The study is enrolling at multiple investigative sites
located in the United States. More information can be found on
www.clinicaltrials.gov, NCT identifier NCT04931459.
About Acumen Pharmaceuticals, Inc.Acumen,
headquartered in Charlottesville, VA, with clinical operations
based in Carmel, IN, is a clinical stage biopharmaceutical company
developing a novel disease-modifying approach to treat Alzheimer’s
disease. Acumen’s scientific founders pioneered research on AβOs,
which a growing body of evidence indicates are primary triggers of
Alzheimer’s disease pathology. Acumen is currently focused on
advancing its investigational immunotherapy drug, ACU193, a
humanized monoclonal antibody that selectively targets toxic AβOs
in a Phase I clinical trial involving early Alzheimer’s disease
patients.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Any
statement describing Acumen’s goals, expectations, financial or
other projections, intentions or beliefs is a forward-looking
statement and should be considered an at-risk statement. Words
such as “believes,” “expects,” “anticipates,” “could,” “would,”
“seeks,” “aims,” “plans,” “potential,” “will” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Forward-looking statements include statements
concerning Acumen’s business and the therapeutic potential of
Acumen’s product candidate, ACU193, including its potential
for improved safety and efficacy as compared to other monoclonal
antibodies in development, as well as the expectations concerning
the INTERCEPT-AD trial. These statements are based upon the current
beliefs and expectations of Acumen management, and are subject to
certain factors, risks and uncertainties, particularly those
inherent in the process of discovering, developing and
commercializing safe and effective human therapeutics. Such risks
may be amplified by the impacts of the COVID-19 pandemic. These and
other risks concerning Acumen’s programs are described in
additional detail in Acumen’s filings with the Securities and
Exchange Commission (“SEC”), including in Acumen’s Quarterly Report
on Form 10-Q for the quarter ended June 30, 2021, filed with the
SEC on August 16, 2021, which is available on the SEC’s website at
www.sec.gov. Copies of these and other documents are available from
Acumen. Additional information will be made available in
other filings that Acumen makes from time to time with the SEC.
These forward-looking statements speak only as of the date hereof,
and Acumen expressly disclaims any obligation to update or revise
any forward-looking statement, except as otherwise required by law,
whether, as a result of new information, future events or
otherwise.
Contact: investors@acumenpharm.com For
more information, visit www.acumenpharm.com.
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