ACU193 Biomarker & Target Engagement from Phase 1 INTERCEPT-AD Study in Early Alzheimer's: Acumen Pharma Presentation at AD/PD™ 2024

Acumen Pharmaceuticals Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company, presented cerebrospinal fluid (CSF) biomarker data from its Phase 1 INTERCEPT-AD trial of sabirnetug (ACU193) at the International Conference on Alzheimer’s and Parkinson’s Diseases in Lisbon. Sabirnetug is a novel humanized monoclonal antibody targeting soluble amyloid beta oligomers (AβOs), believed to be a significant factor in triggering early Alzheimer's disease (AD).

The Phase 1 INTERCEPT-AD trial involved 62 participants and showed positive topline results in July 2023. Notably, the trial demonstrated sabirnetug’s effectiveness in engaging AβOs and suggested its potential as a treatment for early AD. Key findings from CSF biomarker analysis indicated that sabirnetug was associated with decreased levels of neurogranin and pTau181, as well as a trend towards an increasing Aβ42/40 ratio.

Sabirnetug led to significant reductions in CSF levels of neurogranin (-13.9%) and pTau181 (-13.0%) when compared to placebo. There was also a notable correlation between target engagement of AβOs and changes in neurogranin and pTau181 across all doses. These data support the drug’s proposed mechanism and its specific action on AβOs rather than amyloid plaques.

Acumen also developed a novel assay to measure target engagement of AβOs by sabirnetug in the CSF, which showed dose-related increases in target engagement. This new assay configuration is a critical step in understanding how the drug functions in vivo.

Acumen plans to start a Phase 2 trial for sabirnetug in early 2024, alongside a Phase 1 subcutaneous study in mid-2024.

Sabirnetug (ACU193) is designed to selectively target soluble AβOs, which are toxic to neurons and play a key role in Alzheimer’s disease neurodegeneration. Given its encouraging Phase 1 results, sabirnetug has received Fast Track designation from the U.S. Food and Drug Administration for treating early Alzheimer's disease.

The Phase 1 INTERCEPT-AD was a randomized, double-blind, placebo-controlled study in the U.S., involving 65 participants with early-stage AD. It assessed the safety, tolerability, pharmacokinetics, and target engagement of sabirnetug.

Acumen Pharmaceuticals, headquartered in Charlottesville, VA, is focused on developing innovative therapies for Alzheimer's disease. The company's investigational product, sabirnetug, aims to target toxic soluble AβOs, advancing from robust scientific foundations and promising Phase 1 clinical results.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!