Acumen Pharmaceuticals Presents Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer's at the AD/PD™ 2024 Annual Meeting

Core Insights - Acumen Pharmaceuticals is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody targeting soluble amyloid beta oligomers (AβOs) for early Alzheimer's disease (AD) treatment, with promising biomarker results from the Phase 1 INTERCEPT-AD trial [1][2][9] Group 1: Clinical Trial Results - The Phase 1 INTERCEPT-AD trial demonstrated sabirnetug's selective target engagement of AβOs, with positive topline results from 62 participants reported in July 2023 [2] - Key cerebrospinal fluid (CSF) biomarker findings included a significant reduction in neurogranin levels by 13.9% and pTau181 levels by 13.0% compared to the placebo group, indicating improvements in AD pathology [3][4] - The trial showed a dose-dependent trend in CSF levels of pTau181, pTau217, total tau, and the Aβ42/Aβ40 ratio, supporting the drug's pharmacological effects after three administrations [3] Group 2: Future Development Plans - Acumen is on track to initiate a Phase 2 trial evaluating sabirnetug in the first half of 2024 and a Phase 1 subcutaneous study in mid-2024 [1][6] - The company aims to explore the relationship between CSF biomarkers and clinical outcomes in the upcoming Phase 2 study, emphasizing the importance of biomarkers in understanding AD pathology [4] Group 3: Novel Assay Development - Acumen developed a first-of-its-kind assay to measure target engagement of AβOs by sabirnetug, showing clear dose-related increases in target engagement across all cohorts [5][6] - This novel assay is crucial for deepening the understanding of how sabirnetug acts in vivo, as it directly measures the sabirnetug-AβO complex in CSF [6]