Acumen Pharmaceuticals Appoints Dr. Amy Schacterle as Chief Regulatory Officer & Head of Quality
06 Novembro 2024 - 10:00AM
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), announced today the appointment of
Amy Schacterle, Ph.D., as Chief Regulatory Officer & Head of
Quality, reporting to Jim Doherty, President & Chief
Development Officer at Acumen.
“Dr. Schacterle is a highly regarded leader who has successfully
led global regulatory and quality activities across multiple
neurologic and psychiatric therapeutic areas and all stages of
development,” said Dan O’Connell, Chief Executive Officer of
Acumen. “She joins Acumen as we are making considerable clinical
progress with our therapeutic candidate, sabirnetug, and continue
to evolve our development strategy in advance of key clinical data.
We are delighted to have someone with Amy’s deep expertise and
experience in global regulatory and development strategy join our
team in our quest to bring next-generation treatments to the
Alzheimer’s patient community.”
“I also want to express our sincere gratitude to Janice
Hitchcock, Ph.D., Vice President of Regulatory Affairs, who is
retiring at the end of the year. Dr. Hitchcock has led our
regulatory function and has been instrumental in bringing
sabirnetug from IND to Phase 2. She developed the regulatory
strategy supporting our successful Phase 1 INTERCEPT-AD study, and
led our FDA and EMA interactions regarding the design of our Phase
2 ALTITUDE-AD study for sabirnetug that is now ongoing in five
countries,” Mr. O’Connell added.
Dr. Schacterle brings over 30 years of experience in regulatory
affairs, quality assurance, and therapeutic development to Acumen,
with a focus on diseases of the central nervous system. Most
recently, she served as Senior Vice President of R&D Strategy
and Business Management at Sage Therapeutics, where she was
instrumental in portfolio strategy, resource prioritization, and
regulatory leadership. Prior to this role, she was responsible for
building and leading the Regulatory and Quality organizations at
Sage, leading the efforts for the groundbreaking approval of the
first-ever treatment specific for postpartum depression. As Vice
President, Regulatory Affairs at Sunovion Pharmaceuticals
(previously Sepracor) she led the development and commercial
regulatory activities at the company’s Marlborough campus.
“I am excited to be joining Acumen at this pivotal time in the
company’s history and look forward to leading global regulatory
interactions and quality oversight to support the company’s mission
of improving the lives of patients with early Alzheimer’s disease,”
Dr. Schacterle said. “I am thrilled to be a part of the talented
team at Acumen and build on the excellent work done to date as the
company moves toward late-stage development of a potential
next-generation treatment for Alzheimer’s.”
Dr. Schacterle holds a Ph.D. and M.S. in biomedical engineering
from the University of Virginia, and a B.S. in biomedical
engineering from Rensselaer Polytechnic Institute.
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), and
development plans for sabirnetug. 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 Healthcare
AcumenPR@icrhealthcare.com
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