Background

ABBV-916 is a monoclonal antibody to Aβ. It recognizes N-terminal truncated Aβ modified with pyroglutamate at position 3 (N3), a form that is aggregated in amyloid plaques. Its specificity is similar to Lilly’s donanemab and remternetug. The goal with these antibodies is to remove amyloid plaques quickly and completely.

No preclinical data on this antibody have been made public.

Findings

Clinical development began in August 2022, with a trial that was originally listed as Phase 1/2 with an enrollment target of 288, and was subsequently changed to Phase 2 with an enrollement target of 195. Participants must have early, biomarker-confirmed Alzheimer’s disease and be between 50 and 90 years old.

A first stage will assess multiple ascending doses, and a second will study two fixed doses, given monthly for six months, all with placebo control. The primary outcomes for the MAD portion of the study are safety, pharmacokinetics, and immunogenicity of the antibody. In the fixed-dose phase, primary outcomes will be safety and change in brain amyloid by PET scan. All participants will have the option of participating in a two-year, open-label extension. The study, at 88 centers in North America, Europe, and Japan, is anticipated to end in December 2024.

For details on ABBV-916 trials, see clinicaltrials.gov.