Acumen Pharmaceuticals (ABOS) Stifel 2026 Virtual CNS Forum summary

Company background and lead program

• Focused on advancing treatments for Alzheimer's disease, with sabirnetug as the lead candidate, a humanized monoclonal antibody targeting toxic soluble Abeta oligomers.

• Currently running the phase II ALTITUDE-AD study, comparing two active doses versus placebo.

• Developing both IV and subcutaneous (subQ) formulations, with subQ strategy dependent on phase II results.

• Enhanced brain delivery (EBD) program leverages transferrin receptor-mediated transport for improved antibody delivery.

Clinical development and study design

• ALTITUDE-AD phase II study will read out 18-month primary and related outcomes in late 2026.

• Study uses iADRS as the primary endpoint, with CDR Sum of Boxes as a key secondary endpoint.

• Completed enrollment of 542 subjects in 10 months, with the study launched in May 2024 and enrollment finished by March 2025.

• Both selected doses for phase II (35 and 50 mg/kg) are based on phase I pharmacodynamic and biomarker data.

Scientific rationale and differentiation

• Sabirnetug is highly selective for Abeta oligomers, with minimal monomer binding, distinguishing it from other antibodies.

• Phase I data showed robust target engagement, safety, and biomarker effects, supporting rapid progression to phase II.

• The oligomer hypothesis is supported by preclinical and clinical evidence, with sabirnetug designed specifically to neutralize toxic oligomers.