Acumen Pharmaceuticals Reports Phase 1 Results for Sabirnetug Injection in Healthy Volunteers

NEWTON, MA, USA I March 19, 2025 I Acumen Pharmaceuticals, Inc. announced encouraging results from their Phase 1 study examining the pharmacokinetics of sabirnetug administered subcutaneously (SC) versus intravenously (IV) in healthy individuals. Sabirnetug, a promising therapeutic aimed at treating Alzheimer's disease by targeting soluble amyloid beta oligomers (AβOs), demonstrated favorable tolerance and systemic exposure when administered weekly via the SC route, paving the way for further studies.

Daniel O’Connell, CEO of Acumen Pharmaceuticals, expressed optimism about the findings, highlighting the potential for subcutaneous delivery to enhance patient convenience compared to traditional intravenous methods. He emphasized the efficiency and dedication of the clinical team in rapidly advancing the project and confirmed plans to continue with the development of the SC formulation based on these promising results.

The Phase 1 trial involved 28 healthy participants, with 12 receiving a single IV dose of 2,800 mg and 16 receiving four weekly SC doses of 1,200 mg. The most common side effects were mild injection site reactions, observed in 62.5% of the SC group, all of which resolved without further complications. No other safety concerns were identified, and the SC administration resulted in adequate systemic exposure, supporting the feasibility of further trials.

Sabirnetug stands out as the first humanized monoclonal antibody to show selective binding to AβOs in clinical settings. Its SC formulation is enhanced with Halozyme’s ENHANZE® technology, which uses recombinant human hyaluronidase enzyme (rHuPH20) to facilitate large volume SC injections with better dispersion and absorption. This technology has already been validated as part of nine approved therapies.

In addition to the ongoing Phase 1 study, the Phase 2 ALTITUDE-AD trial is underway, evaluating IV sabirnetug's effectiveness in slowing cognitive decline among patients with early Alzheimer's disease. This randomized, double-blind, placebo-controlled study will involve approximately 540 participants across various international sites, including the United States, Canada, the UK, and the European Union.

Sabirnetug, also known as ACU193, was specifically designed to target the soluble AβOs, believed to be potent neurotoxins that contribute to neurodegeneration and synaptic dysfunction in Alzheimer’s disease. By selectively targeting these toxic oligomers, sabirnetug aims to mitigate one of the hypothesized primary drivers of Alzheimer's disease progression. The U.S. Food and Drug Administration has granted sabirnetug Fast Track designation for early Alzheimer’s treatment, underscoring its potential significance.

Acumen Pharmaceuticals, headquartered in Newton, Mass., is a clinical-stage biopharmaceutical company committed to developing groundbreaking therapies for Alzheimer's disease. Their focus on AβOs is based on pioneering research by their scientific founders, which suggests these oligomers are critical early triggers of the disease’s pathology. Building on the positive outcomes from the Phase 1 INTERCEPT-AD trial, Acumen continues to advance sabirnetug in the Phase 2 ALTITUDE-AD study, furthering their mission to address the urgent needs of patients with early symptomatic Alzheimer's disease.