Acumen Pharmaceuticals Presents Innovative Trial Screening Advancements Utilizing pTau217 Assay in Phase 2 Study of Sabirnetug for Early Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease Conference

Late-breaking presentation highlights the pTau217 assay as an effective and efficient tool to screen participants for ALTITUDE-AD that reduces unnecessary amyloid PET scans and lumbar puncture procedures for those who are not eligible

Excerpt from the Press Release:

NEWTON, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) — Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today presented updated data on a validated research-use plasma pTau217 assay to screen potential participants in the ongoing Phase 2 ALTITUDE-AD clinical trial of sabirnetug, at the 17^th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference. The study found that this enrichment screening approach is resulting in a higher proportion of participants who meet the amyloid PET or CSF-based inclusion criteria compared to Acumen’s Phase 1 INTERCEPT-AD trial, which did not use this approach. Furthermore, the enrichment approach is resulting in a more efficient participant selection process that reduces unnecessary amyloid PET scans or lumbar puncture (LP) procedures among people who are not eligible to continue in screening.

“The pTau217 screening assay enrichment approach is an important part of the clinical trial process for Alzheimer’s treatments because it could spare patients from invasive lumbar punctures and unnecessary radiation exposure with an amyloid PET scan,” said Todd Feaster, Psy.D., Senior Clinical Research Scientist at Acumen Pharmaceuticals and the study presenter. “We are encouraged to see that our screening strategy is performing as intended and streamlining the trial enrollment process overall. Screening assays like this can reduce burden for patients, clinical trial investigators and their staff and foster a more compassionate and sustainable clinical trial experience.”

ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug. The study drug will be evaluated in approximately 540 adults ages 50 to 90 years. Thus far, the study is enrolling at 75 sites across the U.S., Canada, EU and U.K. Acumen expects to complete enrollment in the first half of 2025.

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