Acumen Pharmaceuticals has completed participant enrolment in the Phase I INTERCEPT-AD clinical trial of ACU193 in early Alzheimer’s disease (AD) patients.

The US-based, double-blind, multi-centre, placebo-controlled, randomised Phase I clinical trial has been designed for assessing the tolerability, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ACU193, as well as establishing a clinical proof of mechanism.

A total of 65 patients with early AD, mild cognitive impairment, or mild dementia due to AD were enrolled across 17 active sites in the US.

The study includes single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts.

The company commenced the INTERCEPT-AD trial based on the nonclinical trials of ACU193, which support the selective targeting of amyloid beta oligomers (AβOs).

Acumen Pharmaceuticals president and CEO Daniel O’Connell said: “Today’s announcement marks an important milestone for Acumen and the Alzheimer’s community, as we continue to explore ACU193 as a potential therapeutic option for people with early Alzheimer’s disease.

“ACU193 builds on decades of scientific evidence that points to the role of soluble amyloid beta oligomers as primary and persistent toxins in Alzheimer’s pathology.

“By targeting toxic oligomers, we hope to expand the understanding of targets beyond deposited amyloid plaques, which we believe could provide patients with safer and more effective treatment options.”

The clinical stage humanised monoclonal antibody (mAb) ACU193 has been developed for selectively targeting soluble AβOs.

These AβOs are observed to be potent neurotoxins that attach to neurons, inhibit synaptic function, and induce neurodegeneration.

The US Food and Drug Administration (FDA) granted Fast Track designation to ACU193 to treat early AD.