Acumen presents patient experience, biomarker Data from Phase 1 INTERCEPT-AD

Acumen Pharmaceuticals, a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers for the treatment of Alzheimer’s disease, announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug. The research highlights the experiences of patients in the clinical trial to inform development of future trials, biomarker data to support sabirnetug’s mechanism of action, and an ultra-sensitive method of measuring small amounts of sabirnetug in cerebrospinal fluid. The posters will be presented at the Alzheimer’s Association International Conference 2024 taking place in Philadelphia and online from July 28-Aug. 1, 2024. The study revealed that three administrations of sabirnetug significantly lowered CSF levels of both pre- and post-synaptic proteins, consistent with its proposed mechanism of action to inhibit synaptic binding of AbetaOs. VAMP2, a biomarker associated with synaptic injury, was significantly lowered in all multiple ascending dose cohorts and appeared to be the biomarker most sensitive to sabirnetug in this study. Acumen is planning to evaluate longer-term changes in biomarkers and their relationship to clinical outcomes in the ongoing 18-month Phase 2 clinical trial ALTITUDE-AD to further support sabirnetug’s mechanism of action. Acumen developed an ultra-sensitive assay to detect total levels of sabirnetug, both bound and unbound, in CSF. The assay demonstrated sensitivity, accuracy and precision, selectivity, specificity, dilutional linearity, and stability of the method. This development will aid in the accurate quantification of total drug exposure of sabirnetug in clinical trials since only a small fraction of peripherally-administered monoclonal antibodies typically move from blood to the brain. The Phase 2 clinical trial ALTITUDE-AD is designed to evaluate the clinical efficacy and safety of sabirnetug in patients with early AD. The global study is currently enrolling at multiple investigative sites located in the United States and Canada with plans for additional sites in Europe and the U.K.