Treatment of Alzheimer's disease
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Acumen Pharmaceuticals to Present on Recruitment Strategies for Phase 2 ALTITUDE-AD Trial and Enhanced Brain Delivery Technology at 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference
Globenewswire· 2025-11-18 13:00
NEWTON, Mass., Nov. 18, 2025 (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 it will present new findings at the upcoming 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place in San Diego. The presentations include Acumen’s recruitment strategies for its Phase 2 ALTITUDE-A ...
Acumen Pharmaceuticals to Report Third Quarter 2025 Financial Results on November 12, 2025
Globenewswire· 2025-11-05 21:00
Core Insights - Acumen Pharmaceuticals is set to report its third quarter 2025 financial results on November 12, 2025, and will host a conference call for updates [1] - The company is focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease [3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Newton, Massachusetts [3] - The company is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, in a Phase 2 clinical trial for early symptomatic Alzheimer's disease patients [3] - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are believed to be early triggers of Alzheimer's disease pathology [3] - The company is also exploring a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE drug delivery technology and collaborating with JCR Pharmaceuticals for Enhanced Brain Delivery therapy [3]
Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Surpasses 50% Enrollment Target
Globenewswire· 2025-07-01 11:30
Core Viewpoint - Cognition Therapeutics, Inc. has announced that the Phase 2 'START' Study has surpassed 50% enrollment, indicating strong interest in their investigational drug zervimesine for treating early Alzheimer's disease [1][2][3] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [9][10] - The company is currently advancing zervimesine (CT1812), an oral treatment for Alzheimer's disease and dementia with Lewy bodies [5][9] Study Details - The START Study aims to enroll up to 540 individuals with mild Alzheimer's disease, who will receive either zervimesine or a placebo for 18 months [3][7] - The study is supported by an $81 million grant from the National Institute of Aging (NIA) and is conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC) [1][8] Treatment Mechanism - Zervimesine is designed to target the toxic effects of protein buildup in the brain, specifically Aβ and ɑ-synuclein, which are associated with neurodegenerative diseases [5][10] - The treatment has shown promise in previous studies, with the Phase 2 'SHINE' Study indicating a 38% slowing of cognitive decline compared to placebo, and a 95% slowing in participants with lower levels of p-tau217 [4][10] Clinical Significance - The START Study is significant as it targets participants who are just beginning to show signs of cognitive loss, potentially allowing for earlier intervention [4][7] - The study will assess cognitive function and safety using validated tools, contributing to the understanding of zervimesine's efficacy in early Alzheimer's disease [7][8]
Acumen Pharmaceuticals Reports First Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-05-13 11:00
Core Insights - Acumen Pharmaceuticals is focused on developing sabirnetug (ACU193), a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [2][12][14] - The company reported a net loss of $28.8 million for Q1 2025, an increase from $14.9 million in Q1 2024, primarily due to rising R&D expenses [9][21] - Acumen's cash, cash equivalents, and marketable securities totaled $197.9 million as of March 31, 2025, expected to support operations into early 2027 [6][8] Business Update - The Phase 2 study, ALTITUDE-AD, is fully enrolled with 542 participants, and topline results are anticipated in late 2026 [2][4][13] - The company presented at the International Conference on Alzheimer's and Parkinson's Diseases, showcasing the effectiveness of the plasma pTau217 assay in screening participants for ALTITUDE-AD [7] Financial Performance - R&D expenses for Q1 2025 were $25.3 million, up from $12.4 million in Q1 2024, reflecting increased clinical trial costs [8][21] - General and administrative expenses slightly decreased to $5.1 million in Q1 2025 from $5.3 million in Q1 2024 [8][21] - The total operating expenses for Q1 2025 were $30.4 million, compared to $17.8 million in Q1 2024 [8][21] Cash Flow and Balance Sheet - The company reported a net cash used in operating activities of $34.1 million for Q1 2025 [24] - Cash and cash equivalents at the end of Q1 2025 were $30.4 million, down from $47.2 million at the end of Q1 2024 [24]
Acumen Pharmaceuticals to Participate in the Bank of America Healthcare Conference
Globenewswire· 2025-05-07 20:00
Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3] - The company is headquartered in Newton, Massachusetts [3] Product Development - Acumen is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers [3] - The company is currently conducting a Phase 2 clinical trial named ALTITUDE-AD for early symptomatic Alzheimer's disease patients, following positive results from its Phase 1 trial INTERCEPT-AD [3] Upcoming Events - Management will participate in a fireside chat at the Bank of America Healthcare Conference on May 14, 2025, at 8:15 a.m. PT/11:15 a.m. ET [1] - The live webcasts of the event will be accessible under the Investors tab on the company's website and archived for 90 days [2]
Acumen Pharmaceuticals to Report First Quarter 2025 Financial Results on May 13, 2025
Globenewswire· 2025-05-06 20:00
Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3] - The company is headquartered in Newton, Massachusetts [3] Product Development - Acumen is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers [3] - The company is currently conducting a Phase 2 clinical trial named ALTITUDE-AD for early symptomatic Alzheimer's disease patients, following positive results from its Phase 1 trial INTERCEPT-AD [3] Financial Reporting - Acumen Pharmaceuticals will report its first quarter 2025 financial results on May 13, 2025, and will host a conference call and live audio webcast at 8:00 a.m. ET for a business and financial update [1]
Acumen Pharmaceuticals Reports Financial Results for the Year Ended December 31, 2024 and Business Highlights
Globenewswire· 2025-03-27 11:00
Core Insights - Acumen Pharmaceuticals is advancing its clinical development of sabirnetug, a treatment for early Alzheimer's disease, with significant progress reported in 2024 [2][5][12] - The company completed enrollment in its Phase 2 study, ALTITUDE-AD, ahead of schedule and anticipates topline results in late 2026 [5][7] - Financial results for 2024 show a net loss of $102.3 million, an increase from $52.4 million in 2023, primarily due to rising research and development expenses [14][22] Recent Highlights - Enrollment for the Phase 2 ALTITUDE-AD study was completed with 542 participants randomized to receive either sabirnetug or placebo [5][12] - The Phase 1 study results for a subcutaneous formulation of sabirnetug were announced, indicating it is well-tolerated and supports further development [6][11] - Cash, cash equivalents, and marketable securities totaled $231.5 million as of December 31, 2024, expected to fund operations into the first half of 2027 [5][14] Anticipated Milestones - Topline results from the ALTITUDE-AD study are expected in late 2026, focusing on the efficacy and safety of sabirnetug in early Alzheimer's disease [5][7] - The primary endpoint of the ALTITUDE-AD study is the change in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months [6][12] Financial Overview - Research and development expenses increased to $93.8 million in 2024 from $42.3 million in 2023, driven by clinical trial costs and personnel expenses [14][22] - General and administrative expenses rose to $20.2 million in 2024, compared to $18.8 million in 2023 [14][22] - The company reported a loss from operations of $114.0 million in 2024, up from $61.1 million in 2023 [14][22]
Acumen Pharmaceuticals Completes Enrollment of ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer's Disease
Newsfilter· 2025-03-26 12:00
Core Insights - Acumen Pharmaceuticals has completed enrollment in its ALTITUDE-AD Phase 2 trial for sabirnetug (ACU193), targeting early Alzheimer's disease, ahead of schedule and plans to report topline results in late 2026 [1][2][3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [6][7] - The company’s investigational product, sabirnetug (ACU193), is a humanized monoclonal antibody that selectively targets toxic soluble AβOs, which are believed to be a significant factor in the neurodegenerative process of Alzheimer's disease [4][6] Clinical Trial Details - The ALTITUDE-AD trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study that enrolled 542 patients with early Alzheimer's disease across the U.S., Canada, the EU, and the UK [3][5] - Participants were randomized to receive either 35mg/kg or 50mg/kg of sabirnetug or a placebo, with the primary endpoint being the change in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months [3][5] - Secondary endpoints include various cognitive and functional assessments, as well as safety measures [3][5] Previous Trial Results - The Phase 1 INTERCEPT-AD trial indicated that sabirnetug was generally well-tolerated with low rates of ARIA-E and showed significant amyloid plaque reduction compared to placebo at higher doses [2][4]
Acumen Pharmaceuticals Completes Enrollment of ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer’s Disease
Globenewswire· 2025-03-26 12:00
Core Insights - Acumen Pharmaceuticals has completed enrollment in its ALTITUDE-AD Phase 2 trial for sabirnetug (ACU193), targeting early Alzheimer's disease, ahead of schedule and plans to report topline results in late 2026 [1][2][3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [6][7] - The company’s investigational product, sabirnetug (ACU193), is a humanized monoclonal antibody that selectively targets toxic soluble AβOs, which are believed to be a significant factor in the neurodegenerative process of Alzheimer's disease [4][6] Clinical Trial Details - The ALTITUDE-AD trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study that enrolled 542 patients with early Alzheimer's disease across the U.S., Canada, EU, and the UK [3][5] - Participants were randomized to receive either 35mg/kg or 50mg/kg of sabirnetug or a placebo, with the primary endpoint being the change in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months [3][5] - Secondary endpoints include various cognitive and functional assessments, as well as safety measures [3][5] Previous Trial Results - The Phase 1 INTERCEPT-AD trial indicated that sabirnetug was generally well-tolerated with low rates of ARIA-E and showed significant amyloid plaque reduction compared to placebo [2][4]
Acumen Pharmaceuticals to Report Fourth Quarter and Year-End 2024 Financial Results on March 27, 2025
Newsfilter· 2025-03-20 20:00
Core Viewpoint - Acumen Pharmaceuticals is set to report its fourth quarter and year-end 2024 financial results on March 27, 2025, and will host a conference call for updates [1]. Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3]. - The company is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, currently in a Phase 2 clinical trial (ALTITUDE-AD) after positive Phase 1 trial results [3]. - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are recognized as early triggers of Alzheimer's disease pathology [3].