Acumen Pharmaceuticals has dosed the first subject in the open-label extension (OLE) segment of its Phase II Altitude-AD trial of sabirnetug (ACU193) for early Alzheimer’s disease.
This follows the completion of the 18-month placebo-controlled phase, with all completing participants now able to receive sabirnetug at 35mg/kg intravenously every four weeks for another 52 weeks.
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Clinical assessments and safety monitoring will match the placebo-controlled phase.
Sabirnetug is said to be the first humanised monoclonal antibody to show, in individuals with Alzheimer’s, selective target engagement of amyloid beta oligomers (AβOs), soluble synaptotoxic form of Aβ that accumulates early in the disease.
Earlier Phase I Intercept-AD study indicated a favourable safety profile, low ARIA-E rates, biomarker improvements, and target engagement, including reduced amyloid plaques in high-dose groups.
Acumen Pharmaceuticals chief medical officer Eric Siemers said: “Initiating the open-label extension study represents our ongoing commitment to the participants who have contributed in Altitude-AD and provides us with valuable long-term safety and efficacy data.
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By GlobalData“We expect the results of this study to supplement the broader data package supporting sabirnetug, and we look forward to gathering additional insights that will support our continued development of this potentially differentiated therapeutic approach.”
Topline results from Altitude-AD are anticipated in late 2026.
Sabirnetug’s mechanism targets toxic oligomers, aiming to address their central role in early Alzheimer’s pathology.
The US Food and Drug Administration has granted fast track designation to the antibody for treating early stages of the disease.
In March 2025, Acumen concluded enrolment for its multi-centre, double-blind Phase II Altitude-AD trial of sabirnetug in early Alzheimer’s.
