Acumen Pharmaceuticals to Present Patient Experience and Biomarker Insights from Phase 1 INTERCEPT-AD Study at the Alzheimer’s Association International Conference (AAIC®) 2024

NEWTON, Mass., July 11, 2024 (GLOBE NEWSWIRE) — 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 that the Company will present patient experience and biomarker data from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193) at the Alzheimer’s Association International Conference (AAIC®) 2024 taking place in Philadelphia and online from July 28 – Aug. 1, 2024. The posters expand upon biomarker data associated with sabirnetug, methods for detecting levels of sabirnetug in cerebrospinal fluid (CSF), and provide insights on patients’ experiences in the INTERCEPT-AD study to inform future clinical trial considerations for sabirnetug.

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.

Acumen’s presentation details are as follows:

Sunday, July 28
Session: Public Health Epidemiology (7:30 a.m.-4:15 p.m.); Pennsylvania Convention Center

• Poster #684: INTERCEPT-AD: A Gender Analysis of the Phase 1 Experience Among Trial Participants with Early Alzheimer’s Disease and Their Study Partners

Session: Developing Topics: Drug Development (8:00 a.m.- 4:15 p.m.); Pennsylvania Convention Center

• Poster #826: INTERCEPT-AD: Development and Qualification of a Highly Sensitive Immunoassay to Detect Total Sabirnetug (ACU193) in Human CSF

Monday, July 29
Session: Developing Topics: Biomarkers (8:00 a.m.-4:15 p.m.); Pennsylvania Convention Center

• Poster #785: Analysis of CSF Levels of Synaptic Biomarkers Associated with Sabirnetug (ACU193) in INTERCEPT-AD Phase 1 Study in Early AD

Wednesday, July 31
Session: Dementia Care Research and Psychosocial Factors: Psychosocial Factors and Environmental Design (7:30 a.m.-4:15 p.m.)

• Poster #637: INTERCEPT-AD: Understanding the Patient Experience and Expectations for Treatment Through Qualitative Interviews Among Trial Participants with Early Alzheimer’s Disease and Their Study Partners

Members of the Acumen team will also be available at booth #1137 in the Exhibit Hall during the conference to discuss its program and collaborative opportunities.

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 was previously evaluated in a Phase 1 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 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 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 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 Braun
abraun@acumenpharm.com

Media:
Jon Yu
ICR Westwicke
AcumenPR@westwicke.com