Two biotechnology companies are presenting significant advances in Alzheimer's disease research at the 2025 Alzheimer's Association International Conference (AAIC) in Toronto, showcasing both established treatments and novel therapeutic approaches.
Biogen Extends LEQEMBI Data with 48-Month Results
Biogen is highlighting long-term efficacy data for LEQEMBI (lecanemab), presenting 48-month results from the Clarity AD open-label extension study. The company is also introducing a subcutaneous formulation designed for maintenance dosing, potentially offering patients a more convenient treatment option.
"At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer's is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI," said Priya Singhal, M.D., M.P.H., Head of Development at Biogen.
The presentations include real-world evidence from two years post-approval, patient and healthcare professional opinions on the lecanemab autoinjector for subcutaneous delivery, and indirect treatment comparisons of ARIA outcomes between lecanemab and donanemab.
Tau-Targeted Therapy Development
Beyond amyloid-targeting treatments, Biogen is advancing tau-directed therapies with BIIB080, an investigational antisense oligonucleotide (ASO) therapy. The company will present baseline characteristics from CELIA, a Phase 2 study evaluating BIIB080 in participants with early Alzheimer's disease.
BIIB080 is designed to target microtubule-associated protein tau (MAPT) mRNA to reduce tau protein production. Abnormal tau accumulation in the brain is a hallmark of Alzheimer's disease and is associated with neurodegeneration and cognitive decline. The therapy was discovered by Ionis Pharmaceuticals, with Biogen obtaining worldwide exclusive licensing rights in December 2019.
Acumen's Oligomer-Selective Approach
Acumen Pharmaceuticals is presenting data on sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets soluble amyloid beta oligomers (AβOs) rather than amyloid plaques or monomers. The company will share findings on the drug's selectivity compared to lecanemab and aducanumab.
"Our presentation at AAIC highlight how combining biomarker-driven screening with a targeted therapeutic like sabirnetug represents meaningful progress in trial designs and drug development for Alzheimer's disease," said Eric Siemers, M.D., Chief Medical Officer of Acumen Pharmaceuticals.
Cost-Effective Trial Design Innovation
Acumen is also presenting a cost savings analysis demonstrating the economic benefits of using pTau217 as a screening tool in the ongoing Phase 2 ALTITUDE-AD trial. This biomarker-driven approach aims to make clinical trials more patient-centric and efficient.
The ALTITUDE-AD study, initiated in 2024, is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial that has enrolled 542 individuals with early Alzheimer's disease across the United States, Canada, the European Union, and the United Kingdom. Sabirnetug has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of early Alzheimer's disease.
Expanding Educational Initiatives
Biogen is complementing its scientific presentations with educational efforts, hosting an interactive booth offering an immersive journey into tau's role in Alzheimer's disease and expanding resources on KnowTau.com with a new e-learning module.
The presentations at AAIC 2025 reflect the evolving landscape of Alzheimer's disease treatment, with companies pursuing multiple therapeutic targets including amyloid plaques, tau protein, and toxic oligomers while implementing innovative trial designs to improve efficiency and patient outcomes.
