Acumen Pharmaceuticals Appoints Dr. Amy Schacterle as Chief Regulatory Officer & Head of Quality

NEWTON, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- (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 .

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.

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