Acumen Publishes Phase 1 Trial Design and Clinical Development Plan for ACU193, an Anti-Amyloid Beta Oligomer Antibody for Alzheimer’s Disease
November 01 2022 - 8:00AM
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) today announced that it
published its development rationale and clinical development plan
for ACU193, the first clinical-stage monoclonal antibody that
selectively targets toxic soluble amyloid beta oligomers (AβOs).
The article was published in the Journal of Prevention of
Alzheimer’s Disease and outlines the design of its ongoing Phase 1
INTERCEPT-AD trial for ACU193 and planned criteria for advancing to
a Phase 2/3 clinical trial based on recent advancements in clinical
research on Alzheimer’s disease.
ACU193 is a humanized monoclonal antibody
discovered and developed based on its selectivity for soluble AβOs,
which scientific evidence indicates are the most toxic and
pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques.
ACU193 was recently granted Fast Track designation for the
treatment of early Alzheimer’s disease by the U.S. Food and Drug
Administration.
The criteria for advancing from the Phase 1 to a
Phase 2/3 trial will be based on safety and tolerability,
pharmacokinetic parameters, and target engagement at doses that
have acceptable safety and tolerability. The Phase 2/3 trial would
initiate with a patient sample size typical of a Phase 2 trial but
would include an interim analysis to determine whether to increase
the sample size to meet the statistical power of a typical Phase 3
trial. This interim analysis may be based on several cognitive
measures and various biomarkers, including phosphorylated tau in
the blood and cerebrospinal fluid (CSF). Pending discussions with
regulators, if the interim analysis is positive, and the trial is
expanded, the Phase 2/3 trial could potentially serve as a
registration trial.
“Recent clinical results in the Alzheimer’s disease field are
consistent with the concept that targeting Aβ species other than
monomers or amyloid plaques may lead to more effective or safer
disease-modifying treatments that the field has long needed,” said
Eric Siemers, M.D., Chief Medical Officer at Acumen Pharmaceuticals
and first author on the publication. “The Phase 1 trial design and
clinical development plan for ACU193 reflect several advances in
Alzheimer’s disease research methodology and incorporate moving
from a first-in-humans trial directly to a registration-quality
Phase 2/3 trial which uses an adaptive design. Considerable
evidence is available supporting oligomers as a promising
therapeutic target for Alzheimer’s disease, and we are in a
position to more rapidly evaluate this target and accelerate the
development of a new treatment for patients.”
The publication, titled “ACU193, a Monoclonal
Antibody that Selectively Binds Soluble Aβ Oligomers: Development
Rationale, Phase 1 Trial Design, and Clinical Development Plan,”
can be viewed online here.
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 what
a growing body of evidence indicates is a primary underlying cause
of the neurodegenerative process in AD.
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
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
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 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 Phase 1 INTERCEPT‐AD
trial and the development of a subsequent Phase 2/3 trial, and
expectations with respect to the role of toxic soluble AβOs in the
potential treatment of Alzheimer’s disease. 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 Annual Report on Form 10‐K for the year ended December 31,
2021, filed with the SEC on March 28, 2022, which is available on
the SEC’s website at www.sec.gov, and its other documents
subsequently filed with or furnished to 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.
Contacts:
Media:AcumenPR@westwicke.com
Investors:investors@acumenpharm.com
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