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Acumen Antibody Granted Fast Track Designation for Alzheimer's Disease

Acumen Antibody Granted Fast Track Designation for Alzheimer's Disease

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.

Acumen Pharmaceuticals develops therapeutics for Alzheimer's Disease (AD) based upon the discovery and characterization of amyloid-derived diffusible ligands (ADDLs). Acumen Pharmaceuticals, Inc. was incorporated in 1996 and is headquartered in Charlottesville, Virginia.

Alzheimer’s disease (AD) currently affects over 6 million people in the U.S. and approximately 32 million people worldwide. By 2050, these numbers are expected to roughly triple and healthcare costs in the U.S. alone will exceed 1 trillion dollars without effective measures to prevent or slow the disease. AD is now the sixth-leading cause of death in the U.S., and it is likely to continue rising in the absence of more efficacious treatments.

October 26, 2022

https://www.fdanews.com/





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