www.fdanews.com/articles/209945-acumen-antibody-granted-fast-track-designation-for-alzheimers-disease
Acumen Antibody Granted Fast Track Designation for Alzheimer's Disease
October 26, 2022
The FDA has granted Fast Track designation to Acumen Pharmaceuticals’ ACU193 for the treatment of patients with early Alzheimer’s disease.
ACU193 is a monoclonal antibody that selectively targets soluble amyloid beta oligomers, which are believed to be the initiating pathologic agents that cause Alzheimer’s. The oligomers are a toxic form of beta amyloid, which is a normal product of brain metabolism. ACU193 binds to the amyloid beta oligomers and blocks the toxic effect on brain synapses.
ACU193 is currently being studied in a phase 1 clinical trial to assess the antibody’s mode of action and its safety.