Acumen Pharmaceuticals to Present Deeper Insights, Including Fluid Biomarker Data for Sabirnetug (ACU193), During Emerging Science Session at the American Academy of Neurology Annual Meeting

2024-03-21

临床1期快速通道临床2期

- Company on track to initiate Phase 2 trial evaluating sabirnetug in first half of 2024

CHARLOTTESVILLE, Va., March 21, 2024 (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 the Company will present data from its Phase 1 INTERCEPT-AD study evaluating sabirnetug (ACU193) in early AD during an Emerging Science Session at the American Academy of Neurology (AAN) Annual Meeting in Denver, Colo., and online on Tuesday, April 16.

Acumen’s sabirnetug is the first humanized monoclonal antibody to clinically demonstrate target engagement of AβOs, a soluble and highly toxic form of Aβ that accumulates early in AD and triggers synaptic dysfunction and neurodegeneration.

Acumen’s presentation will include deeper insights into the safety, target engagement and biomarker findings from INTERCEPT-AD. Presentation details are as follows:

Platform Presentation: 007 - A phase 1 study, INTERCEPT-AD, of ACU193: safety, target engagement, and biomarker changes, 6:06 PM – 6:12 PM MDT

Poster Q&A: 6:25 PM – 7:00 PM MDT

Presenting Author: Eric Siemers, M.D., Chief Medical Officer, Acumen Pharmaceuticals

Topic: Aging, Dementia, Cognitive, and Behavioral Neurology

Platform Session and Poster Q&A Date & Time: Tuesday, April 16, 5:30 PM – 7:00 PM MDT

“There’s been tremendous progress in the field of Alzheimer’s disease over the last few years and a particular interest in the use of biomarkers for a variety of neurological conditions,” said Daniel O’Connell, President and Chief Executive Officer of Acumen. “We’re eager to present more extensive findings from our sabirnetug program, which further our understanding of key biomarkers associated with AD and support broader efforts that can aid in diagnosis and treatment of this devastating disease.”

Acumen is on track to initiate a Phase 2 trial evaluating sabirnetug in the first half of 2024.

About Sabirnetug (ACU193)

Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble 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 directly address a growing body of evidence indicating that soluble AβOs are a primary underlying cause of the neurodegenerative process in Alzheimer’s disease. Sabirnetug 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 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, headquartered in Charlottesville, VA, with additional offices in Indianapolis, IN and Newton, MA, 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, following positive results 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 “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), Acumen’s preparations with respect to its plans to initiate a Phase 2 study. 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:

ICR Westwicke

AcumenPR@westwicke.com