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

ACU193 is the first monoclonal antibody to enter a clinical trial that has been discovered and is under development to selectively target toxic beta-amyloid oligomers (AβO)

Acumen announced the first patient dosage in INTERCEPT-AD in October 2021 and the recruitment of patients with early-stage Alzheimer’s disease is underway

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

Toxic soluble AβOs have been found to interact in synapses of brain cells called neurons, resulting in impaired neuronal function and can initiate and perpetuate the process of neurodegeneration, ultimately leading to cell death.

“We believe that research conducted for more than two decades has indicated that toxic soluble Aβ oligomers are a promising therapeutic target for Alzheimer’s disease,” said Eric Siemers, MD, medical director of Acumen. “ACU193 is distinguished by its selective targeting of Aβ oligomers, offering the possibility of short-term improvements in synaptic function in addition to a potential long-term modification of the disease with a slowing of the Alzheimer’s disease process. We believe that oligomer-specific therapies are less likely to cause amyloid-related imaging abnormalities – or ARIA – a major safety concern for plaque-targeting drugs.

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

Oral presentation details:

  • Presentation number: OC3

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

  • Presenter: Eric Siemers, MD, Medical Director, Acumen Pharmaceuticals

  • Date and hour : Wednesday November 10, 2021; 9:20 a.m. ET

  • Site: Boston Park Plaza, Grand Ballroom A

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

About ACU193
ACU193 is a monoclonal antibody (mAb) discovered and developed on the basis of its selectivity for soluble AβO, which, according to Acumen, is the most toxic and pathogenic form of Aβ compared to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins which 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 to be the main underlying cause of the neurodegenerative process of AD.

About INTERCEPT-AD
About 62 people with early-onset AD (mild cognitive impairment or mild dementia due to AD) are expected to be randomized in this first, double-blind, placebo-controlled human study to ACU193. INTERCEPT-AD is designed to establish security and proof mechanism. It consists of single ascending dose (SAD) and multiple ascending dose (MAD) cohorts and is designed to assess the safety, tolerability, pharmacokinetics (PK) and target commitment of intravenous doses of ACU193. The study is part of several investigation sites located in the United States. More information can be found at www.clinicaltrials.gov, NCT identifier NCT04931459.

About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals, headquartered in Charlottesville, Virginia, with clinical operations based in Carmel, Indiana, is a clinical-stage biopharmaceutical company developing a new disease-modifying approach to treat Alzheimer’s disease. The scientific founders of Acumen pioneered research into toxic soluble AβOs, which, according to a growing body of evidence, are the main triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its research product candidate, ACU193, a humanized monoclonal antibody that selectively targets toxic soluble AβO in a Phase 1 clinical trial involving patients with early-onset Alzheimer’s disease. 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 objectives, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered as a risk statement. Words such as “believes”, “expects”, “anticipates”, “might”, “would”, “research”, “aims”, “plans”, “‘forward-looking statements, although all forward-looking statements do not contain these identifying words. Forward-looking statements include statements regarding the business of Acumen and the therapeutic potential of Acumen’s product candidate, ACU193, including its potential to improve safety and efficacy over other monoclonal antibodies in development. , as well as expectations for the INTERCEPT-AD trial. These statements are based on 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 therapies. These risks may be magnified by the impacts of the COVID-19 pandemic. These and other risks relating to Acumen’s programs are further described in documents filed by Acumen 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, available on the SEC’s website at www.sec.gov. Copies of these and other documents are available from Acumen. Additional information will be available in other documents filed by Acumen 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.

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