Acumen Pharmaceuticals Shares Phase 1 INTERCEPT-AD Study Data at AAIC 2024

Acumen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm, has revealed new insights from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193). This research focuses on the experiences of patients in the clinical trial, biomarker data supporting the drug's mechanism, and a new ultra-sensitive method for measuring minimal amounts of sabirnetug in cerebrospinal fluid (CSF). The findings will be showcased at the upcoming Alzheimer’s Association International Conference (AAIC®) 2024 in Philadelphia.

Sabirnetug is a significant development as the first humanized monoclonal antibody to show selective engagement of toxic soluble amyloid beta oligomers (AβOs) in patients with early symptomatic Alzheimer’s disease (AD). These AβOs are harmful forms of amyloid beta that emerge early in AD, triggering synaptic dysfunction and neurodegeneration. Acumen aims to make sabirnetug a leading antibody treatment for early symptomatic AD.

Dr. Eric Siemers, Chief Medical Officer of Acumen, emphasized the strength of their Phase 1 study design involving early symptomatic AD participants, reinforcing sabirnetug’s potential as a top-tier treatment. The research underscores the importance of integrating patient perspectives in drug development and confirms the mechanism of action of sabirnetug. The study also involves developing robust tools to measure the drug’s presence and effect in patients, aiding the progression of future clinical trials, including the ongoing Phase 2.

Acumen's approach to understanding the patient experience involved conducting exit interviews with patients from the INTERCEPT-AD trial. This was aimed at grasping their experiences with mild cognitive impairment and mild AD, along with their treatment expectations. Feedback was gathered on the decision-making process, trial experience, and gender-specific responses, to improve future trial designs. Most participants reported memory and cognitive difficulties, and expressed a desire for treatments to slow or halt disease progression, maintain recognition of loved ones, and enhance communication abilities.

The study also found that three doses of sabirnetug significantly lowered CSF levels of synaptic proteins, aligning with its proposed action of inhibiting synaptic binding of AβOs. VAMP2, a biomarker linked to synaptic injury, was notably reduced across multiple dose cohorts, proving highly sensitive to sabirnetug. Acumen aims to investigate longer-term biomarker changes and clinical outcomes in its ongoing 18-month Phase 2 trial, ALTITUDE-AD, to further substantiate the drug's mechanism.

To accurately measure sabirnetug levels in CSF, Acumen developed an ultra-sensitive assay, demonstrating high sensitivity, accuracy, precision, and stability. This tool is crucial for quantifying total drug exposure in trials since only minimal amounts of monoclonal antibodies typically travel from blood to brain.

The ALTITUDE-AD Phase 2 trial, initiated in 2024, seeks to evaluate the clinical efficacy and safety of sabirnetug in slowing cognitive and functional decline in early AD patients. This global study is currently enrolling participants in the U.S. and Canada, with plans for additional sites in Europe and the UK. The trial aims to involve around 540 individuals with early AD.

Sabirnetug (ACU193) is a humanized monoclonal antibody developed to target toxic soluble amyloid beta oligomers (AβOs), which are potent neurotoxins contributing to AD pathology. By targeting AβOs, sabirnetug aims to tackle the underlying cause of neurodegeneration in AD. The drug has received Fast Track designation from the U.S. FDA for early AD treatment and is currently under evaluation in the Phase 2 ALTITUDE-AD trial.

Acumen Pharmaceuticals is dedicated to developing innovative treatments targeting AβOs for Alzheimer’s disease. Their investigational candidate, sabirnetug, is advancing through clinical trials following positive Phase 1 outcomes. The company is based in Newton, Mass.

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