-- Topline data show that ALTITUDE-AD did not meet the primary endpoint of change from baseline in cognitive and functional decline as measured by the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months compared to placebo at either dose; key secondary endpoints, including CDR-SB, also did not achieve statistical significance --
-- Acumen to cease clinical development of sabirnetug, preserve cash and explore strategic options --
NEWTON, Mass., Oct. 30, 2026 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) ("Acumen" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that initial topline data from its Phase 2 ALTITUDE-AD clinical trial of sabirnetug (ACU193) in participants with early AD did not meet its primary endpoint of change from baseline in cognitive and functional decline as measured by the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months compared to placebo at either the 35 mg/kg or the 50 mg/kg dose. The trial also failed to achieve statistical significance on key secondary efficacy endpoints, including the Clinical Dementia Rating – Sum of Boxes (CDR-SB), and did not show any meaningful difference between either sabirnetug treatment arm and the placebo arm. Sabirnetug was generally well tolerated, with amyloid-related imaging abnormalities - edema (ARIA-E) observed in ~10% of sabirnetug-treated participants. An analysis of change in amyloid plaque load, as measured by positron emission tomography (PET) SUVr, demonstrated statistically significant amyloid plaque reduction for both dose levels at week 36 and week 76.
Acumen expects to receive and analyze additional data from ALTITUDE-AD in the coming weeks, including fluid biomarker and additional imaging data, but does not expect these data to change the efficacy conclusions of the trial.
Based on the initial topline results, Acumen plans to cease development of sabirnetug, including the open-label extension portion of the ALTITUDE-AD trial, and to evaluate its strategic options, including its Enhanced Brain Delivery™ (EBD®) program. In the interim, the Company plans to take steps to implement cash conservation measures and explore strategic options to maximize shareholder value.