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Acumen Pharmaceuticals to Present Clinical Trial Design for INTERCEPT-AD, the Phase 1 Placebo-Controlled, Single- and Multiple-Dose Clinical Trial of ACU193, at 2021 Clinical Trials on Alzheimer’s Disease (CTAD) Conference

·5 min read

ACU193 is the first monoclonal antibody to enter a clinical trial that was discovered and is being developed to selectively target toxic amyloid-beta oligomers (AβOs)

Acumen announced dosing of first patient in INTERCEPT-AD in October 2021 and enrollment of patients with early Alzheimer’s disease is ongoing

CHARLOTTESVILLE, Va. and CARMEL, Ind., Nov. 02, 2021 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer’s disease (AD), today announced the company will deliver an oral presentation on the clinical trial framework of its product candidate, ACU193, at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference, being held in-person and virtually November 9-12 in Boston. ACU193 is a monoclonal antibody that selectively targets toxic soluble amyloid-beta oligomers (AβOs) for the treatment of early Alzheimer’s disease.

Toxic soluble AβOs have been found to interact within synapses of brain cells called neurons, which leads to altered neuronal function, and may initiate and perpetuate the process of neurodegeneration, ultimately leading to cell death.

“We believe research over more than two decades has pointed toward toxic soluble Aβ oligomers as a promising therapeutic target for Alzheimer’s disease,” said Eric Siemers, M.D., Chief Medical Officer at Acumen. “ACU193 is differentiated in its selective targeting of Aβ oligomers, providing the possibility of short-term improvements in synaptic function in addition to potential long-term disease modification with slowing of the Alzheimer’s disease process. We believe that oligomer-specific therapeutics are less likely to result in amyloid-related imaging abnormalities – or ARIA – a major safety concern for plaque-targeting drugs.”

Dr. Siemers’ presentation at CTAD will discuss the scientific rationale for targeting AβOs, the clinical trial design of the Phase 1 INTERCEPT-AD study of ACU193, and how the study is designed to measure potential improvements in cognition and blood flow in the brain.

Details of the oral presentation:

  • Presentation number: OC3

  • Presentation Title: Phase 1 trial design for ACU193, a monoclonal antibody that selectively binds soluble Aβ oligomers

  • Presenter: Eric Siemers, M.D., Chief Medical Officer, Acumen Pharmaceuticals

  • Date & Time: Wednesday, Nov. 10, 2021; 9:20 a.m. ET

  • Location: Boston Park Plaza, Grand Ballroom A

The presentation will be streamed live on the CTAD digital platform and a recorded version of the presentation will be available within 48 hours after the event on the CTAD website for those registered for the meeting.

About ACU193
ACU193 is a 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 what a growing body of evidence indicates is a primary underlying cause of the neurodegenerative process in AD.

About INTERCEPT-AD
Approximately 62 individuals with early AD (mild cognitive impairment or mild dementia due to AD) are expected to be randomized into this double-blind, placebo-controlled, first-in-human study of ACU193. INTERCEPT-AD is designed to establish safety and proof of mechanism. It 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 is enrolling at multiple investigative sites located in the United States. More information can be found on www.clinicaltrials.gov, NCT identifier NCT04931459.

About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals, headquartered in Charlottesville, Va. with clinical operations based in Carmel, Ind., is a clinical stage biopharmaceutical company developing a novel disease-modifying approach to treat Alzheimer’s disease. Acumen’s scientific founders pioneered research on toxic soluble AβOs, which a growing body of evidence indicates are primary 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 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,” “would,” “seeks,” “aims,” “plans,” “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 Acumen’s business and the therapeutic potential of Acumen’s product candidate, ACU193, including its potential for improved safety and efficacy as compared to other monoclonal antibodies in development, as well as the expectations concerning the INTERCEPT-AD trial. 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 the COVID-19 pandemic. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 16, 2021, which is available on the SEC’s website at www.sec.gov. 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.

Contacts:

Media:
AcumenPR@westwicke.com

Investors:
investors@acumenpharm.com