echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Study of Nervous System > Express Innovative Alzheimer's disease monoclonal antibody received FDA Fast Track designation

    Express Innovative Alzheimer's disease monoclonal antibody received FDA Fast Track designation

    • Last Update: 2022-11-05
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Recently, Acumen Pharmaceuticals announced that its new drug ACU193 has been granted fast-track designation by the FDA for the treatment of early-stage Alzheimer's disease
    。 The company notes that ACU193 is a monoclonal antibody
    that selectively targets toxic soluble amyloid oligomers (AβOs) β.


    Alzheimer's disease (AD) is the most common neurodegenerative disease in older people, but it is not a normal aging process, and complex changes in the brain occur 20 years before symptoms begin, eventually leading to brain cell death or loss of
    bonds.
    Amyloid deposition is a hallmark feature of the patient's brain, and targeting amyloid is one of the important directions for the development of new drugs for
    Alzheimer's disease.

    ACU193 is a selective humanized monoclonal antibody
    developed for soluble AβOs.
    Acumen believes that AβOs is the most toxic and pathogenic form
    compared to Aβ amyloid monomer and amyloid plaque.
    Soluble AβOs has been observed to bind to neurons, inhibit synaptic function and induce neurodegeneration, and is a potent neurotoxin
    .
    ACU193 is able to bind to AβOs, and due to its unique binding properties, ACU193 has the potential to provide therapeutic benefit at a low risk of developing amyloid-associated imaging abnormalities (ARIA, a common major side effect of antibody therapy) because ACU193 can block the toxic effects
    of AβOs without directly targeting amyloid plaques.

    ACU193 is currently undergoing a double-blind, placebo-controlled, Phase 1 human study that is expected to enroll 62 patients with early-stage AD (mild cognitive impairment or mild dementia due to AD) to evaluate the safety, tolerability, pharmacokinetics (PK) and targeting of intravenous ACU193 and demonstrate its mechanism
    .

    Daniel O'Connell, President and Chief Executive Officer of Acumen, said, "We are pleased that ACU193 has fast-track designation, which reflects the potential clinical role
    of this drug in the treatment of Alzheimer's disease.
    We look forward to working with the FDA to advance the development of
    ACU193.
    " Treating Alzheimer's disease requires a multi-pronged approach to different parts of the pathway, and we developed ACU193 to provide patients with more treatment options
    .





    To learn more about the application of cutting-edge technologies in the biomedical industry, please long press and scan the QR code above to access the "WuXi Live Room".
    Watch live discussions and replays

    on related topics [1] Acumen’s ACU193, an Anti-Amyloid Beta Oligomer Antibody, Granted FDA Fast Track Designation for Alzheimer's Disease.
    Retrieved October 24, 2022, from https://investors.
    acumenpharm.
    com/news-releases/news-release-details/acumens-acu193-anti-amyloid-beta-oligomer-antibody-granted-fda

    Disclaimer: WuXi AppTec's content team focuses on global biomedical health research progress
    .
    This article is for information exchange purposes only, and
    the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views
    in this article.
    This article is also not a treatment recommendation
    .
    For guidance on treatment options, go to a regular hospital
    .



    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.