Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage
biopharmaceutical company developing a novel therapeutic that
targets soluble amyloid beta oligomers (AβOs) for the treatment of
Alzheimer’s disease (AD), today announced that it will present
topline results from a Phase 1 trial of its candidate ACU193, the
first clinical stage AβO-directed antibody therapy, at the
Alzheimer’s Association International Conference (AAIC®) 2023
taking place in Amsterdam, Netherlands and online from July 16-20,
2023. As part of a Featured Research Session - Developing Topics
platform, four presentations will be made that discuss the Phase 1
trial.
Decades of research have shown that soluble AβOs are a
distinctly toxic form of Aβ, based on their propensity to bind to
neurons, disrupt synapses and contribute to tau
hyper-phosphorylation. ACU193 is a humanized monoclonal antibody
that selectively targets toxic soluble AβOs and may prevent AβOs
from binding to synapses and disrupting neuronal function.
“We are excited to present the first clinical data from our
Phase 1 INTERCEPT-AD trial to the scientific and medical community
at AAIC, including evidence of the overall safety profile,
pharmacokinetic data, and target engagement of ACU193,” said Daniel
O’Connell, President and Chief Executive Officer of Acumen. “This
will also mark the first clinical proof-of-mechanism data in the
field from a monoclonal antibody with high selectivity for toxic
amyloid beta oligomers, highlighting the potential of a
differentiated antibody product that targets early and persistent
triggers of Alzheimer’s pathology. We believe the INTERCEPT-AD
trial is an important step to developing a next generation
treatment with a compelling benefit-risk balance for patients with
early Alzheimer’s disease.”
Topline INTERCEPT-AD data will be presented in a Featured
Research Session as part of the Developing Topics program on
Sunday, July 16, 2023 from 8 a.m. – 8:45 a.m. CEST (2 a.m. – 2:45
a.m. ET). The session will be co-chaired by Dr. Eric Siemers,
Acumen’s Chief Medical Officer, and Dr. Kimball Johnson, Medical
Director of iResearch Atlanta and iResearch Savannah and an
INTERCEPT-AD trial investigator.
The session will include the following presentations:
Abstract: #82615Title: Baseline characteristics
of INTERCEPT-AD: A phase 1 trial with ACU193 targeting soluble
amyloid beta oligomers for the treatment of early Alzheimer’s
disease
Abstract: #82860Title: Recruitment strategies
and tactics for INTERCEPT-AD: A phase I trial of Aβ
oligomer-targeting ACU193 in early Alzheimer’s disease
Abstract: #82934Title: Eligibility in the
INTERCEPT-AD trial: Visual amyloid classification for equivocal
SUVrs in early Alzheimer’s disease
Abstract: #82821Title: INTERCEPT-AD: A phase 1
trial of Aβ oligomer-targeting ACU193 in early Alzheimer’s
disease
Conference Call Details
Acumen will host a webcast presentation and conference call for
analysts and investors on Monday, July 17, 2023, at 8 a.m. ET to
discuss the data from the INTERCEPT-AD clinical trial. The webcast
will feature members of Acumen’s leadership team as well as Steven
DeKosky, MD, Deputy Director of the McKnight Brain Institute at the
University of Florida and member of Acumen’s scientific advisory
board, and Lawrence Honig, MD, PhD, Director of the New York State
Center of Excellence for Alzheimer's Disease at Columbia University
and an INTERCEPT-AD trial investigator.
To participate in the live conference call, please register
using this link. After registration, you will be informed of
the dial-in numbers including PIN.
The webcast audio will be available via this link.
An archived version of the webcast will be available for at
least 30 days in the Investors section of the Company's website at
www.acumenpharm.com.
About ACU193
ACU193 is a humanized monoclonal antibody (mAb) discovered and
developed based on its selectivity for soluble 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 a growing body
of evidence indicating that soluble AβOs 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 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) enrolled in 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. 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 early and persistent 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 Acumen’s
business, and the therapeutic potential of Acumen’s product
candidate, ACU193, including against other antibodies, and the
anticipated timeline for reporting topline data. 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
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 most recent Annual Report on Form 10-K, and
in subsequent filings with the SEC, including Acumen’s most recent
Quarterly Report on Form 10-Q. 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
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