Acumen Pharmaceuticals has reported that its Phase I INTERCEPT-AD trial of ACU193 for the treatment of early Alzheimer’s Disease (AD) has met the primary and secondary objectives.
The placebo-controlled, double-blind, randomised, multi-centre, single-ascending-dose and multiple-ascending-dose cohort study in the US assessed the tolerability, safety, pharmacokinetics (PK), and target engagement of ACU193 in patients with mild cognitive impairment or mild dementia due to AD.
A total of 65 subjects with early AD were randomised to receive an intravenous administration of 2mg/kg, 10mg/kg, 25mg/kg and 60mg/kg of ACU193, an amyloid beta oligomer (AβOs)-targeting antibody therapy.
Higher doses, including 60mg/kg given every four weeks and 25mg/kg every two weeks, demonstrated a statistically significant reduction in amyloid plaque load. It was determined using an amyloid positron emission tomography after six to 12 weeks (from baseline to endpoint within cohorts (p = 0.01)).
Acumen Pharmaceuticals president and CEO Daniel O’Connell said: “ACU193’s observed dose-related central target engagement, rapid reduction of amyloid plaque and compelling safety profile validate our confidence in ACU193’s differentiated mechanism of action: selectively targeting AβOs.
“We believe that the robust data package generated by this comprehensive Phase I study establishes ACU193’s broad therapeutic index and guides a future clinical dosing rationale.
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“We look forward to an anticipated interaction with the FDA in the fourth quarter to inform our next phase of development for ACU193.”
However, exploratory measures including changes in cerebral blood flow, and assessment of cognition did not show discernible effects from the immediate administration of ACU193.
The assessment of biomarkers of downstream neurodegeneration is at present in progress.
ACU193 is a humanised monoclonal antibody (mAb) that selectively targets toxic soluble AβOs, which are determined as potent neurotoxins for inducing neurodegeneration and inhibiting synaptic function.