Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), 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 new
findings from its Phase 1 INTERCEPT-AD study of sabirnetug
(ACU193). The research highlights the experiences of patients in
the clinical trial to inform development of future trials,
biomarker data to support sabirnetug’s mechanism of action, and an
ultra-sensitive method of measuring small amounts of sabirnetug in
cerebrospinal fluid (CSF). The posters will be presented at the
Alzheimer’s Association International Conference (AAIC®) 2024
taking place in Philadelphia and online from July 28-Aug. 1, 2024.
Sabirnetug is the first humanized monoclonal
antibody to demonstrate in patients with early symptomatic AD
selective target engagement of AβOs, a soluble and highly toxic
form of Aβ that accumulates early in AD and is a persistent trigger
of synaptic dysfunction and neurodegeneration. Acumen is developing
sabirnetug as a potential best-in-class antibody treatment for
early symptomatic AD.
“These findings from our Phase 1 study of
sabirnetug highlight not only the strength of the study design with
participants having early symptomatic AD but also continue to
support the potential for sabirnetug as a best-in-class treatment,"
said Eric Siemers, M.D., Chief Medical Officer of Acumen. “Our
research reflects our focus on incorporating the patient voice into
drug development, provides further support for the mechanism of
action of sabirnetug, and includes developing powerful tools for
drug development with an assay that can measure even small amounts
of sabirnetug bound to toxic soluble amyloid beta oligomers in
patients in our clinical trials. These insights can help us as we
advance clinical studies of sabirnetug, including our ongoing Phase
2 study. As recently approved therapies for Alzheimer’s gain
traction, we have an opportunity to advance a next-generation
treatment that has the potential to optimize the benefit-risk ratio
compared to first-generation disease-modifying treatments for
AD.”
Understanding the Patient Experience in
INTERCEPT-AD
Acumen is putting patients first by
incorporating the patient voice in drug development. Acumen
conducted exit interviews in a subset of patients from the
INTERCEPT-AD trial to understand their experience with MCI and mild
AD and expectations for treatment. Acumen also obtained feedback on
topics such as the decision-making process preceding trial
enrollment and the overall trial experience, and examined the
results by participant gender to guide planning for future clinical
trials. Participants reported a broad array of symptoms consistent
with AD, most frequently difficulty with memory or cognitive
functioning. Nearly every participant desired treatment that would
keep the disease from getting worse or slow progression.
Additionally, participants wanted a new treatment that would help
them maintain the ability to recognize loved ones and maintain or
improve communication abilities.
Sabirnetug Lowers CSF Levels of Synaptic
Biomarkers
The study revealed that three administrations of
sabirnetug significantly lowered CSF levels of both pre- and
post-synaptic proteins, consistent with its proposed mechanism of
action to inhibit synaptic binding of AβOs. VAMP2, a biomarker
associated with synaptic injury, was significantly lowered in all
multiple ascending dose cohorts and appeared to be the biomarker
most sensitive to sabirnetug in this study. Acumen is planning to
evaluate longer-term changes in biomarkers and their relationship
to clinical outcomes in the ongoing 18-month Phase 2 clinical trial
ALTITUDE-AD to further support sabirnetug’s mechanism of
action.
Developing a Highly Sensitive Assay to Detect
Sabirnetug in CSF
Acumen developed an ultra-sensitive assay to
detect total levels of sabirnetug, both bound and unbound, in CSF.
The assay demonstrated sensitivity, accuracy and precision,
selectivity, specificity, dilutional linearity, and stability of
the method. This development will aid in the accurate
quantification of total drug exposure of sabirnetug in clinical
trials since only a small fraction of peripherally-administered
monoclonal antibodies typically move from blood to the brain.
The Phase 2 clinical trial ALTITUDE-AD (NCT06335173) is designed
to evaluate the clinical efficacy and safety of sabirnetug in
patients with early AD. The global study is currently enrolling at
multiple investigative sites located in the United States and
Canada with plans for additional sites in Europe and the UK.
About Sabirnetug
(ACU193)Sabirnetug (ACU193) is a humanized monoclonal
antibody (mAb) discovered and developed based on its selectivity
for soluble amyloid beta oligomers (AβOs), which are a highly 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,
sabirnetug aims to address the hypothesis that soluble AβOs are an
early and persistent underlying cause of the neurodegenerative
process in Alzheimer’s disease (AD). Sabirnetug has been granted
Fast Track designation for the treatment of early AD by the U.S.
Food and Drug Administration and is currently being evaluated in a
Phase 2 study in patients with early AD.
About INTERCEPT-AD (Phase
1)Completed in 2023, INTERCEPT-AD was 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
sabirnetug in patients with early Alzheimer’s disease (AD).
Sixty-five individuals with early symptomatic AD (mild cognitive
impairment or mild dementia due to AD) enrolled in this
first-in-human study of sabirnetug. The INTERCEPT-AD study
consisted of single-ascending-dose (SAD) and
multiple-ascending-dose (MAD) cohorts and was designed to evaluate
the safety, tolerability, pharmacokinetics (PK), and target
engagement of intravenous doses of sabirnetug. More information can
be found on www.clinicaltrials.gov, NCT identifier
NCT04931459.
About ALTITUDE-AD (Phase
2)Initiated in 2024, ALTITUDE-AD is a Phase 2,
multi-center, randomized, double-blind, placebo-controlled clinical
trial designed to evaluate the efficacy and safety of sabirnetug
(ACU193) intravenous infusions administered once every four weeks
in slowing cognitive and functional decline as compared to placebo
in participants with early Alzheimer's disease. The study will
enroll approximately 540 individuals with early Alzheimer’s disease
(mild cognitive impairment or mild dementia due to AD). The global
study is currently enrolling at multiple investigative sites
located in the United States and Canada with plans for additional
sites in Europe and the UK. More information can be found on
www.clinicaltrials.gov, NCT identifier NCT06335173.
About Acumen Pharmaceuticals,
Inc. Acumen Pharmaceuticals 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, sabirnetug (ACU193), a humanized
monoclonal antibody that selectively targets toxic soluble AβOs, in
its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in
early symptomatic Alzheimer’s disease patients, following positive
results in its Phase 1 trial INTERCEPT-AD. The company is
headquartered in Newton, Mass. 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 “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 the therapeutic potential and potential
clinical efficacy of Acumen’s product candidate, sabirnetug
(ACU193). These statements are based upon the current beliefs and
expectations of Acumen’s 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. 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:Jon YuICR Westwicke
AcumenPR@westwicke.com
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