{"id":70375,"date":"2025-07-28T12:01:39","date_gmt":"2025-07-28T12:01:39","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2025\/07\/28\/acumen-pharmaceuticals-presents-studies-showing-the-utility-of-a-ptau217-assay-in-screening-for-a-phase-2-alzheimers-disease-trial-and-validates-sabirnetug-oligomer-selectivity-at-the-alzhei\/"},"modified":"2025-07-28T12:01:39","modified_gmt":"2025-07-28T12:01:39","slug":"acumen-pharmaceuticals-presents-studies-showing-the-utility-of-a-ptau217-assay-in-screening-for-a-phase-2-alzheimers-disease-trial-and-validates-sabirnetug-oligomer-selectivity-at-the-alzhei","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/acumen-pharmaceuticals-presents-studies-showing-the-utility-of-a-ptau217-assay-in-screening-for-a-phase-2-alzheimers-disease-trial-and-validates-sabirnetug-oligomer-selectivity-at-the-alzhei\/","title":{"rendered":"Acumen Pharmaceuticals Presents Studies Showing the Utility of a pTau217 Assay in Screening for a Phase 2 Alzheimer\u2019s Disease Trial and Validates Sabirnetug Oligomer-Selectivity, at the Alzheimer\u2019s Association International Conference (AAIC) 2025"},"content":{"rendered":"<div>\n<p align=\"justify\">NEWTON, Mass., July  28, 2025  (GLOBE NEWSWIRE) &#8212; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gusTOnmcrU88VhuP_gk79MqO7v6cy7LuLs7prCowvxWKVs-cSYx6cMoW7W6PDvwIbvnjfjNvCPsPwhQVbZk02-_S2fFn7mU9rWD6vf4tdQYqIBLbqPvaeGMdiR2W0ndcn1OANd9_CJXrU7ls-JWvZ-eZ5ClXdQSEsVQnPB4YiTA-FnTdle0B7iiTdm7b-O3E6DChQSAB1gJ1n2wtrVRcCsFSNKrwTaCD37-f0NBNXO0gnhKE0ZtrSmpWyeGY5Tq4lsrQC3D0aj4Av7_0nQlMIQ==\" rel=\"nofollow\" target=\"_blank\" title=\"Acumen Pharmaceuticals, Inc.\">Acumen Pharmaceuticals, Inc.<\/a>\u00a0(NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (A\u03b2Os) for the treatment of Alzheimer\u2019s disease (AD), today announced results showing that implementing a blood-based pTau217 screening assay reduced Acumen\u2019s overall clinical trial screening costs by approximately 40% in its Phase 2 ALTITUDE-AD study of sabirnetug in early Alzheimer\u2019s disease in the U.S. and Canada. Additionally, a nonclinical study revealed sabirnetug achieved the highest selectivity for A\u03b2Os over A\u03b2 monomers relative to recombinant lecanemab and aducanumab. The results are being presented at the Alzheimer&#8217;s Association International Conference (AAIC), taking place July 27-31, 2025, in Toronto and online.<\/p>\n<p align=\"justify\">\u201cThese advances represent important progress in addressing the critical need for effective treatments targeting toxic amyloid \u03b2 oligomers (A\u03b2Os) in early symptomatic Alzheimer&#8217;s disease, while simultaneously demonstrating patient-centric and cost-effective trial execution strategies,\u201d said Eric Siemers, M.D., Chief Medical Officer of Acumen Pharmaceuticals. \u201cBy combining cutting-edge therapeutic development with smart clinical trial strategies, we&#8217;re working to create a more efficient path forward in bringing potential new options to patients with Alzheimer\u2019s disease. &#8220;<\/p>\n<p align=\"justify\"><strong>ALTITUDE-AD: Cost savings using a pTau217 screening assay in an ongoing Phase 2 study of sabirnetug in early Alzheimer&#8217;s disease<\/strong><\/p>\n<p align=\"justify\">Acumen reported operational innovations in its ALTITUDE-AD Phase 2 clinical trial where researchers implemented an innovative two-step screening process using plasma pTau217 biomarker assay testing that yielded significant clinical trial screening and cost efficiencies. The approach reduced total screening costs by approximately 40% across U.S. and Canadian sites.<\/p>\n<p align=\"justify\">Furthermore, the screening process was efficient, with 48% of participants meeting the pTau217 threshold required for confirmatory testing. Among those who passed this initial screening, 81% of participants successfully met amyloid positivity eligibility requirements. The strategy performed as intended, helping to achieve strong enrollment rates and reducing unnecessary amyloid PET scans and lumbar puncture procedures for potential participants.<\/p>\n<p align=\"justify\"><strong>Sabirnetug shows superior selectivity for A\u03b2 oligomers over monomer, a differentiated mechanism of action.<\/strong>\u00a0<\/p>\n<p align=\"justify\">Soluble, synaptotoxic A\u03b2Os are an early and persistent driver of AD-related pathophysiology and represent a key target for the development of next-generation therapies for Alzheimer\u2019s disease. Targeting soluble A\u03b2Os may slow down neurodegeneration, reduce tau hyperphosphorylation, and prevent synapse loss for patients with early AD.<\/p>\n<p align=\"justify\">Acumen demonstrated sabirnetug&#8217;s selectivity for binding to toxic A\u03b2Os through comprehensive surface plasmon resonance testing. The study revealed sabirnetug achieved the highest binding affinities to A\u03b2O preparations among the monoclonal antibodies tested. Sabirnetug also showed minimal interaction with monomeric A\u03b2, which is significant given that monomeric forms are approximately 7,000-fold more abundant than oligomers in the cerebrospinal fluid of patients with MCI and mild dementia due to AD. Overall, sabirnetug demonstrated 8,750-fold selectivity for A\u03b21-42 stabilized oligomers over A\u03b21-40 monomers. The results support sabirnetug\u2019s mechanism of action and selectivity for A\u03b2Os.<\/p>\n<p><strong>About Sabirnetug (ACU193)<\/strong><\/p>\n<p align=\"justify\">Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (A\u03b2Os), which are a highly toxic and pathogenic form of A\u03b2, relative to A\u03b2 monomers and amyloid plaques. Soluble A\u03b2Os have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble A\u03b2Os, sabirnetug aims to address the hypothesis that soluble A\u03b2Os are an early and persistent underlying cause of the neurodegenerative process in Alzheimer\u2019s 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.<\/p>\n<p><strong>About ALTITUDE-AD (Phase 2)<\/strong><\/p>\n<p align=\"justify\">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&#8217;s disease. The study has enrolled 542 individuals with early Alzheimer\u2019s disease (mild cognitive impairment or mild dementia due to AD) at multiple investigative sites located in the United States, Canada, the European Union and the United Kingdom. More information can be found on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=cCkwvUFeoqiq0rVW0NKonyST7pLTVixzgCEfmMTvjEp0_fYpjF3AJ4o2aScJQBwTS40pZ329TwUTdjxtHxYgcutF9FE3UNr9eJAx-rNxK8w=\" rel=\"nofollow\" target=\"_blank\" title=\"www.clinicaltrials.gov\">www.clinicaltrials.gov<\/a>, NCT identifier NCT06335173.<\/p>\n<p><strong>About Acumen Pharmaceuticals, Inc. <\/strong><\/p>\n<p align=\"justify\">Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (A\u03b2Os) for the treatment of Alzheimer\u2019s disease (AD). Acumen\u2019s scientific founders pioneered research on A\u03b2Os, which a growing body of evidence indicates are early and persistent triggers of Alzheimer\u2019s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets synaptotoxic A\u03b2Os, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer\u2019s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. Acumen is also investigating a subcutaneous formulation of sabirnetug using Halozyme\u2019s proprietary ENHANZE<sup>\u00ae<\/sup> drug delivery technology. Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery (EBD\u2122) therapy for Alzheimer\u2019s disease utilizing a transferrin-receptor-targeting blood-brain barrier-penetrating technology. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.<\/p>\n<p><strong>Forward-Looking Statements<\/strong><\/p>\n<p align=\"justify\">This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen\u2019s 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 \u201cpotential,\u201d \u201cwill\u201d 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\u2019s product candidate, sabirnetug (ACU193) and the efficiencies and costs associated with the pTau217 screening assay. These statements are based upon the current beliefs and expectations of Acumen\u2019s 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\u2019s programs are described in additional detail in Acumen\u2019s filings with the Securities and Exchange Commission (\u201cSEC\u201d), including in Acumen\u2019s 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.<\/p>\n<p><strong>Investors:<\/strong><br \/>Alex Braun<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=4yz64dEhRqkbg9cdOveAl3da1PPki9Tsl1j4G-U2VCR3uFUXQRwCmAWYHdLrzJICOP71dP7JI0RgDCSxbylqLALLUTavzgjeAF8tqoR5fYVPRLv6KAiBa8TSitFtK44VeuS83eewkH7O-qNCzjJ0RtDKRDN7nEpJLa2gZrBU35-KJ4e-Z8f4iFNiHL5J6sBeSHpwnktGOSU5TJqkh_sBqNitS6KwBVaDanKrzF64HARw45oHEJJbxQY4xC0iz-qBlgryVl4A-yndbmTUiEUVGA==\" rel=\"nofollow\" target=\"_blank\" title=\"abraun@acumenpharm.com\">abraun@acumenpharm.com<\/a><\/p>\n<p><strong>Media:<\/strong><br \/>Jon Yu<br \/>ICR Healthcare<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gusTOnmcrU88VhuP_gk79BcWRMDeO0jgDMDAt2sIJ_Zg-ne5uYTKhQWyqZsXIqiO-_b015qjVsODIL73aSSAaRbFaAXNuHc94lFRzu_Hp-WNL8bFSmZziihFiKDJlDWw6M9CWu6pEEqku2iKHZ7mkWxYLwd_HrE2_9LNSZH-aibXiSd8sjkZi9Quhx_7RkR4zxZxpIf_9L_SgPyy1YYdP6J8573rPynnBPTrk2jGuZ8lTFhAxz8coMFOkLFI_OBztEKtTwUmRj59OMSsmzUpJQCUFxhuIXUAd2bUY8ACRov8Q3-DE9EW1xcfl0RLFE4B\" rel=\"nofollow\" target=\"_blank\" title=\"AcumenPR@icrhealthcare.com\">AcumenPR@icrhealthcare.com<\/a><\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/MDhjNzdlMWMtNzJmZC00N2RhLTljZDEtZjIwMzI4YmFkOThkLTEyMjIyMzUtMjAyNS0wNy0yOC1lbg==\/tiny\/Acumen-Pharmaceuticals-Inc-.png\" referrerpolicy=\"no-referrer-when-downgrade\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>NEWTON, Mass., July 28, 2025 (GLOBE NEWSWIRE) &#8212; Acumen Pharmaceuticals, Inc.\u00a0(NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (A\u03b2Os) for the treatment of Alzheimer\u2019s disease (AD), today announced results showing that implementing a blood-based pTau217 screening assay reduced Acumen\u2019s overall clinical trial screening costs by approximately 40% [&#8230;]\n","protected":false},"author":1,"featured_media":70376,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-70375","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - 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