Acumen Pharmaceuticals Completes Enrollment in Phase 1 Trial of ACU193, First Monoclonal Antibody Developed to Selectively Target Toxic Aβ Oligomers in Patients with Early Alzheimer’s Disease
February 13 2023 - 8:00AM
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the
“Company”), a clinical-stage biopharmaceutical company developing a
novel therapeutic that targets toxic soluble amyloid beta oligomers
(AβOs) for the treatment of Alzheimer’s disease (AD), today
announced the completion of enrollment in its Phase 1 INTERCEPT-AD
trial of ACU193 in patients with early Alzheimer’s disease. Acumen
is on track to report topline results, including safety and
proof-of-mechanism data, in the third quarter of 2023, which is
earlier than previously expected.
“Today’s announcement marks an important
milestone for Acumen and the Alzheimer’s community as we continue
to explore ACU193 as a potential therapeutic option for people with
early Alzheimer’s disease,” said Daniel O’Connell, President and
Chief Executive Officer of Acumen Pharmaceuticals. “ACU193 builds
on decades of scientific evidence that points to the role of
soluble amyloid beta oligomers as primary and persistent toxins in
Alzheimer’s pathology. By targeting toxic oligomers, we hope to
expand the understanding of targets beyond deposited amyloid
plaques which we believe could provide patients with safer and more
effective treatment options.”
The Phase 1 INTERCEPT-AD trial enrolled 65
subjects across 17 active sites in the United States. This
randomized, placebo-controlled Phase 1 trial is designed to assess
safety and proof of mechanism of ACU193. The trial was initiated
based on encouraging nonclinical studies of ACU193 that support the
selective targeting of AβOs.
ACU193 is the first clinical-stage monoclonal antibody developed
to selectively target soluble AβOs, which are among the most toxic
and pathogenic forms of Aβ relative to Aβ monomers and deposited
amyloid plaque. Toxic soluble AβOs have been found to interact
within synapses, which leads to altered neuronal function, and can
initiate and perpetuate the process of neurodegeneration.
For more information on INTERCEPT-AD (NCT04931459), please visit
www.clinicaltrials.gov.
About ACU193
ACU193 is a humanized monoclonal antibody (mAb)
discovered and developed based on its selectivity for soluble
amyloid beta oligomers (AβOs), which Acumen believes are the most
toxic and pathogenic form of Aβ, relative to Aβ monomers and
amyloid plaques. Soluble AβOs have been observed to be potent
neurotoxins that bind to neurons, inhibit synaptic function and
induce neurodegeneration. By selectively targeting toxic soluble
AβOs, ACU193 aims to directly address what a growing body of
evidence indicates is 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 INTERCEPT-AD
INTERCEPT-AD is 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
Alzheimer’s disease (AD). Sixty-five individuals with early AD
(mild cognitive impairment or mild dementia due to AD) have been
randomized into this first-in-human study of ACU193. The
INTERCEPT-AD study 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 has completed
enrollment across 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 therapeutic that
targets toxic soluble amyloid beta oligomers (AβOs) 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 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, as
well as the expectations concerning the timing of data for 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,
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, 2021, and future filings with the SEC,
including Acumen’s Quarterly Report on Form 10-Q for the quarter
ended and September 30, 2022. 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.
Investors:Alex Braunabraun@acumenpharm.com
Media:AcumenPR@westwicke.com
Acumen Pharmaceuticals (NASDAQ:ABOS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Acumen Pharmaceuticals (NASDAQ:ABOS)
Historical Stock Chart
From Jul 2023 to Jul 2024