Acumen Pharmaceuticals, Inc. announced that ACU193, the first clinical-stage monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers (AβOs), has been granted Fast Track designation for the treatment of early Alzheimer’s disease by the FDA. ACU193 is currently being studied in the Phase 1 INTERCEPT-AD trial designed to assess safety and proof of mechanism of ACU193.
ACU193 is a humanized monoclonal antibody discovered and developed based on its selectivity for soluble AβOs, which scientific evidence shows are the most toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Some types of toxic soluble AβOs have been found to interact within synapses which leads to altered neuronal function, and can initiate and perpetuate the process of neurodegeneration, ultimately leading to cell death. ACU193 binds AβOs that bind to synapses, and due to its unique binding profile, ACU193 has potential to provide therapeutic benefit with low risk of amyloid-related imaging abnormalities (ARIA), because ACU193 blocks the toxic effects of AβOs without directly targeting amyloid plaques.
“We are encouraged to receive Fast Track designation for ACU193, reflecting its potential clinical utility to treat Alzheimer’s disease,” said Daniel O’Connell, President and Chief Executive Officer of Acumen. “We look forward to collaborating with the FDA to advance the development of ACU193. Treating Alzheimer’s disease ultimately requires therapies that target different components of the disease pathway, and we are developing ACU193 with the goal of providing patients with more treatment options.”
The FDA Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions with the potential to fill an unmet medical need. The Fast Track designation allows Acumen to have more frequent engagement with the FDA to discuss development plans and clinical study design for ACU193 to ensure collection of appropriate data to support evaluation for approval.
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