Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the
“Company”), a clinical-stage biopharmaceutical company developing a
novel therapeutic that targets toxic globular soluble amyloid beta
oligomers (sAβOs) for the treatment of Alzheimer’s disease (AD),
has demonstrated the utility of a human in vitro model of
iPSC-derived excitatory neurons for a better understanding of which
forms of amyloid beta oligomers contribute to the pathogenesis of
AD in the human brain. This research will be presented in a poster
at the International Conference on Alzheimer’s and Parkinson’s
Diseases and related neurological disorders (AD/PD), held in-person
in Gothenburg, Sweden, and virtually March 28 – April 1, 2023.
There is considerable scientific evidence that
supports the role of toxic forms of soluble aggregates of Aβ, such
as oligomers and protofibrils, in the pathogenesis of AD. Soluble
AβOs have been found to bind at synapses, which leads to altered
neuronal function, and can initiate and perpetuate the process of
neurodegeneration. However, soluble AβOs exist in many forms –
including globular and linear conformations, a wide range of size
distributions, and diverse epitope displays – and it remains
unclear which of these species are most relevant to AD
pathogenesis. Soluble AβOs have been challenging to model in the
laboratory even though they have been identified in the
cerebrospinal fluid (CSF) of AD patients; their concentrations are
low in CSF, and an understanding of their diversity, especially
with regard to molecular weights in the human brain, needs
additional refinement.
Utilizing human iPSC-derived excitatory neurons
as a model, a panel of Aβ detection antibodies, and a panel of
globular sAβOs plus monomers, the current study found that sAβ size
may influence synaptic binding. Regardless of sAβ preparation or
detection antibody, low-molecular weight sAβ species
(monomers-trimers) demonstrated the lowest levels of detectable
synaptic binding, compared with those of mid- and high-molecular
weight (> 150 kDa).
This research complements Acumen’s ongoing
clinical development of ACU193, a humanized monoclonal antibody
candidate that selectively targets toxic globular sAβOs. Acumen
recently completed patient enrollment in INTERCEPT-AD, a Phase 1,
U.S.-based, multi-center, randomized, double-blind,
placebo-controlled clinical trial evaluating the safety and
tolerability, and establishing clinical proof of mechanism, of
ACU193 in patients with early AD. The Company plans to initiate a
Phase 2 trial of ACU193 with the potential to expand into a Phase 3
trial.
“We believe that these research efforts
contribute to the development of next-generation therapies with
higher selectivity for toxic soluble amyloid species that are most
relevant to Alzheimer’s pathogenesis,” said Erika Cline, Ph.D.,
lead author and Manager of Bioanalytical Methods at Acumen
Pharmaceuticals. “Studies assessing how different soluble AβO
species bind to synapses are important for identifying AβO
preparations that will help bridge the understanding of how
AβO-targeting antibodies behave in biochemical assays and in vivo.
Furthermore, models utilizing human neurons have the potential to
accelerate the identification of prime targets for clinical drug
development. Together with Acumen’s ongoing Phase 1 clinical trial
of ACU193, we aim to provide proof of mechanism data that we
believe will shed additional light on the role of toxic oligomeric
species in Alzheimer’s disease.”
The poster, “Binding of Soluble Amyloid Beta
Oligomer Species to Human iPSC-Derived Excitatory Neurons Assessed
Using a Panel of Aβ Antibodies” (P0007 / #1726), will become
available on Tuesday, March 28, 2023 and will be presented
throughout the conference beginning on March 29.
About ACU193
ACU193 is a humanized monoclonal antibody (mAb)
discovered and developed based on its selectivity for soluble
amyloid beta oligomers (sAβOs), which Acumen believes are more
toxic forms of Aβ, relative to Aβ monomers and amyloid plaques.
Globular sAβOs have been observed to be potent neurotoxins that
bind to neurons, inhibit synaptic function and induce
neurodegeneration. By selectively targeting toxic globular sAβOs,
ACU193 aims to directly address a growing body of evidence
indicating that sAβOs are a primary underlying cause of the
neurodegenerative process in Alzheimer’s disease. ACU193 has been
granted Fast Track designation for the treatment of early
Alzheimer’s disease by the U.S. Food and Drug Administration.
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 therapeutic that
targets toxic globular soluble amyloid beta oligomers (sAβOs) for
the treatment of Alzheimer’s disease (AD). 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 product candidate, ACU193, a humanized monoclonal
antibody that selectively targets toxic globular soluble AβOs in
INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s
disease patients. For more information, visit
www.acumenpharm.com.
Forward-Looking Statements
This 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,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,”
“will,” “milestone” 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 the
therapeutic potential of Acumen’s product candidate, ACU193, and
amyloid beta oligomers. 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,
geopolitical events and macroeconomic conditions, such as rising
inflation and interest rates, supply disruptions and uncertainty of
credit and financial markets. 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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2022, and future filings with the SEC.
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.
ContactsInvestors:Alex
Braunabraun@acumenpharm.com
Media:AcumenPR@westwicke.com
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