Acumen Pharmaceuticals, Inc. announced that it will present deeper insights and new exploratory findings from its Phase 1 INTERCEPT-AD trial evaluating ACU193, the first clinical-stage AßO-directed antibody therapy for early AD, at the 16th Annual Clinical Trials on Alzheimer?s Disease (CTAD) conference taking place in Boston and online from October 24-27, 2023. INTERCEPT-AD was selected to be featured in a symposium on Friday, October 27, and data from exploratory analyses of the Phase 1 trial will also be shared in two in-person and two virtual poster presentations. Decades of research have shown that soluble AßOs are a highly toxic form of Aß, based on their propensity to bind to neurons, disrupt synapses and contribute to tau hyper-phosphorylation.

ACU193 is the first clinical-stage antibody designed to selectively bind AßOs, inhibiting their ability to disrupt synaptic function, while potentially offering improved safety and clinical benefit over existing amyloid-directed therapies. In July of this year, Acumen announced topline results from its INTERCEPT-AD trial which demonstrated that ACU193 was well-tolerated with a compelling overall safety profile, meeting the primary objective of this Phase 1 study in both single and multiple doses in 60 participants with early AD. ACU193 is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble AßOs, which Acumen believes are the most toxic and pathogenic form of Aß, relative to Aß monomers and amyloid plaques.

Soluble AßOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AßOs, ACU193 aims to directly address a growing body of evidence indicating that soluble AßOs are a primary underlying cause of the neurodegenerative process in Alzheimer?s disease. ACU193 has been granted Fast Track designation for the treatment of early Alzheimer?s disease by the U.S. Food and Drug Administration.

INTERCEPT-AD is a Phase 1, U.S.-based, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and tolerability, and establishing clinical proof of mechanism, of ACU193 in patients with early Alzheimer?s disease (AD). Sixty-five individuals with early AD (mild cognitive impairment or mild dementia due to AD) enrolled in this first-in-human study of ACU193. The INTERCEPT-AD study 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.