Phase 1 INTERCEPT-AD data published in Journal of Prevention of Alzheimer's Disease supports continued development of sabirnetug (ACU193) for treatment of early Alzheimer's disease (AD)

Sabirnetug demonstrated selective, dose-dependent target engagement of amyloid beta oligomers (AβOs), statistically significant amyloid plaque reduction within higher dose cohorts, and low overall levels of ARIA-E

Phase 2 ALTITUDE-AD clinical trial of sabirnetug is ongoing with enrollment completion expected 1H 2025

NEWTON, Mass., Jan. 09, 2025 (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 Journal of Prevention of Alzheimer's Disease published the results of the Phase 1 INTERCEPT-AD clinical trial demonstrating that sabirnetug (ACU193) was generally well-tolerated with dose- and exposure-dependent target engagement and reduction in amyloid plaques.

Acumen is developing sabirnetug as a potential next-generation antibody treatment for early symptomatic AD. Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in patients with early symptomatic AD. Soluble AβOs are a highly toxic form of Aβ that begin to accumulate before a clinical diagnosis of symptomatic AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration.

"The robust data package generated by this Phase 1 study provides important evidence of sabirnetug's safety profile, further confirms the mechanism of action of sabirnetug and establishes the foundation for our ongoing Phase 2 ALTITUDE-AD clinical trial, including the doses used in ALTITUDE-AD," said Eric Siemers, M.D., Chief Medical Officer of Acumen. "We are pleased to highlight the strength of our study design and the creation of advanced tools for drug development, including an assay that can detect very small amounts of sabirnetug bound to toxic soluble amyloid beta oligomers in human cerebrospinal fluid."

INTERCEPT-AD was a randomized, double-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the safety and tolerability of sabirnetug in patients with early AD. A total of 65 individuals with early AD (mild cognitive impairment or mild dementia due to AD) enrolled in this first-in-humans study of sabirnetug. The results, which were previously presented at scientific congresses, demonstrated selective target engagement of AβOs in a dose-dependent and exposure-dependent manner, statistically significant amyloid plaque reduction within higher dose multiple-ascending dose cohorts, and low overall levels of amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) or hemorrhage/hemosiderin deposition (ARIA-H). One participant experienced mildly symptomatic ARIA-E, which resolved within four weeks. None of the six participants who were apolipoprotein E Ɛ4 homozygotes and received sabirnetug developed ARIA-E or ARIA-H.

"The publication of this data in the Journal of Prevention of Alzheimer's Disease is a significant milestone in our ongoing clinical development of sabirnetug, and reflects our commitment to advancing the collective understanding about the underlying pathology of Alzheimer's disease and developing a next-generation treatment for this burdensome disease," said Daniel O'Connell, Chief Executive Officer of Acumen.

The publication titled, "INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease," is available online here.

ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug in patients with early Alzheimer's disease. The study drug will be evaluated in approximately 540 adults ages 50 to 90 years. Thus far, the study is enrolling at 75 sites across the U.S., Canada, EU and U.K. The first patient was dosed in ALTITUDE-AD in May 2024, and Acumen expects to complete enrollment in the first half of 2025.

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 is currently being evaluated in a Phase 2 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 symptomatic 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 , NCT identifier NCT04931459.

About ALTITUDE-AD (Phase 2)

Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. The study will enroll approximately 540 individuals with early Alzheimer's disease (mild cognitive impairment or mild dementia due to AD). The global study is currently ongoing at multiple investigative sites located in the United States, Canada, the United Kingdom, and the European Union. More information can be found on , NCT identifier NCT06335173.

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 the timing of enrollment completion of the ALTITUDE-AD trial. 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 Healthcare
AcumenPR@icrhealthcare.com