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Acumen Pharmaceuticals Announces Topline Results from Phase 1 Study of Subcutaneous Formulation of Sabirnetug in Healthy Volunteers
Newsfilter· 2025-03-19 12:00
Core Insights - Acumen Pharmaceuticals announced positive topline results from its Phase 1 study of sabirnetug, indicating that subcutaneous administration is well-tolerated and supports further clinical development [1][2] - The company emphasizes the potential for increased patient convenience with the subcutaneous formulation compared to intravenous treatment [2] - Sabirnetug is the first humanized monoclonal antibody to demonstrate selective target engagement of soluble amyloid beta oligomers (AβOs) in Alzheimer's disease patients [3][5] Clinical Study Details - The Phase 1 study involved 12 healthy volunteers receiving single intravenous doses of 2,800 mg and 16 subjects receiving four weekly subcutaneous doses of 1,200 mg [2] - The most common adverse events were mild injection site reactions, occurring in 62.5% of subjects, with no significant safety concerns identified [2] - The ongoing Phase 2 ALTITUDE-AD study is evaluating the efficacy and safety of sabirnetug in patients with early Alzheimer's disease [4][6] Technology and Mechanism - Sabirnetug is co-formulated with Halozyme's ENHANZE® drug delivery technology, which enhances subcutaneous delivery by allowing larger volumes to be administered [3][7] - The drug targets toxic soluble AβOs, which are believed to play a critical role in the neurodegenerative process of Alzheimer's disease [5][9] Company Overview - Acumen Pharmaceuticals is focused on developing therapies targeting soluble AβOs for Alzheimer's disease and is headquartered in Newton, Massachusetts [9]
Acumen Pharmaceuticals to Present During International Conference on Alzheimer’s and Parkinson’s Diseases 2025 and American Academy of Neurology Annual Meeting
Globenewswire· 2025-03-12 12:00
Core Insights - Acumen Pharmaceuticals is advancing sabirnetug (ACU193), a humanized monoclonal antibody targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment [6][8] - Upcoming scientific presentations at major conferences will focus on the implementation of a plasma pTau217 assay and the effects of sabirnetug on synaptic biomarkers in Alzheimer's disease [1][2] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Newton, Massachusetts, focusing on therapies for Alzheimer's disease [8] - The company has received Fast Track designation from the U.S. FDA for sabirnetug, which is currently in a Phase 2 clinical trial [6][8] Clinical Trials - The ALTITUDE-AD study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of sabirnetug in early Alzheimer's disease patients [7] - Approximately 540 individuals with early Alzheimer's disease are being enrolled in the ALTITUDE-AD study, which is ongoing across multiple sites in the U.S., Canada, UK, and EU [7] Upcoming Presentations - Acumen will present findings at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders in Vienna from April 1-5, 2025, and at the American Academy of Neurology Annual Meeting in San Diego from April 5-9, 2025 [1][2] - Oral presentations will include the use of plasma pTau217 screening in the ALTITUDE-AD study, while poster presentations will cover various methodologies related to AβOs and synaptic biomarkers [2][3]