• Topline results for ACU193, the first clinical stage amyloid beta oligomer (AβO)-directed antibody, to provide deeper insight into candidate’s therapeutic potential for the treatment of early Alzheimer’s disease
• Phase 1 INTERCEPT-AD data investigating safety, pharmacokinetics and target engagement of ACU193 to be included in a Featured Research Session as a Developing Topics oral presentation on July 16
  
• Company to host conference call and webcast for investors and analysts July 17 at 8 a.m. ET

CHARLOTTESVILLE, Va. and CARMEL, Ind., June 13, 2023 (GLOBE NEWSWIRE) -- 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: #82615
Title: 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: #82860
Title: Recruitment strategies and tactics for INTERCEPT-AD: A phase I trial of Aβ oligomer-targeting ACU193 in early Alzheimer’s disease

Abstract: #82934
Title: Eligibility in the INTERCEPT-AD trial: Visual amyloid classification for equivocal SUVrs in early Alzheimer’s disease

Abstract: #82821
Title: 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:
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