Acumen Announces First Patient Dosed in a Phase 1 Clinical Trial of Monoclonal Antibody
Acumen Pharmaceuticals, Inc. recently announced dosing of the first patient in INTERCEPT-AD, the Phase 1 placebo-controlled, single- and multiple-dose clinical trial of ACU193, a monoclonal antibody that selectively targets toxic amyloid-beta oligomers (AβOs) for the treatment of early AD.
“We are very pleased to report this first clinical development milestone for ACU193,” said Daniel O’Connell, President and CEO of Acumen. “We are encouraged by recent momentum and the breadth of scientific innovation that is being applied to Alzheimer’s research. We believe ACU193 has distinct potential to address the continued unmet medical needs of people living with Alzheimer’s disease.”
ACU193 is a monoclonal antibody (mAb) discovered and developed based on its selectivity for AβOs, which Acumen believes are the most toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic AβOs, ACU193 aims to directly address what a growing body of evidence indicates is a primary underlying cause of the neurodegenerative process in AD.
“We are all very excited about evaluating ACU193 in the INTERCEPT-AD trial,” said Eric Siemers MD, Chief Medical Officer for Acumen. “Our goal for this Phase 1 clinical trial is to establish proof of mechanism for ACU193, including overall safety and tolerability, pharmacokinetics and target engagement. We have also incorporated standard clinical outcomes for AD as well as exploratory assessments. Based on ACU193’s unique mechanism of action, we believe it has the potential for improved efficacy and for improved safety compared to other monoclonal antibodies in development.”
Approximately 62 individuals with early AD (mild cognitive impairment or mild dementia due to AD) are expected to be randomized into this double-blind, placebo-controlled, first-in-human study of ACU193. INTERCEPT-AD is designed to establish safety and proof of mechanism. It consists of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and target engagement of intravenous doses of ACU193. The study is enrolling at multiple investigative sites located in the United States. More information can be found on www.clinicaltrials.gov, NCT identifier NCT04931459.
Acumen, headquartered in Charlottesville, VA, with clinical operations based in Carmel, IN, is a clinical-stage biopharmaceutical company developing a novel disease-modifying approach to treat Alzheimer’s disease. Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are primary triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational immunotherapy drug, ACU193, a humanized monoclonal antibody that selectively targets toxic AβOs in a Phase 1 clinical trial involving early Alzheimer’s disease patients.
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