US-based Acumen Pharmaceuticals announced that its ACU193 therapy has shown positive topline results in the Phase 1 INTERCEPT-AD trial for early Alzheimer’s disease.

ACU193 is a humanised monoclonal antibody (mAb). It was discovered and developed because of its selectivity for soluble amyloid beta oligomers (AβOs).

In the trial, ACU193 met the primary and secondary objectives in both single and multiple doses in 60 participants with early AD. The dose levels were two, 10, 25 and 60 mg/kg for one to three doses given intravenously.

According to an analysis of change in amyloid plaque load, the therapy showed a rapid, dose-related mean reduction at the higher dose levels studied.

Acumen said that the results are comparable to mean amyloid plaque reduction of approved Aß monoclonal antibodies at similar time points in their clinical development phase.

It achieved maximal central target engagement of toxic AβOs beyond expected levels to set up a broad therapeutic index and enable smooth monthly dosing ​.

Additionally, ACU193 was generally well-tolerated in patients with early Alzheimer’s disease with no drug-related serious adverse events and a low rate of ARIA-E across all cohorts.

Acumen president and CEO Daniel O’Connell said: “We are very pleased to present the first clinical data from our Phase 1 INTERCEPT-AD study at AAIC.

“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 amyloid beta oligomers.

“We believe that the robust data package generated by this comprehensive Phase 1 study establishes ACU193’s broad therapeutic index and guides a future clinical dosing rationale.

“We look forward to an anticipated interaction with the FDA in the fourth quarter to inform our next phase of development for ACU193.”

INTERCEPT-AD is a Phase 1, multi-centre, randomised, double-blind, placebo-controlled clinical trial which enrolled 65 individuals with early AD.

The company plans to present the full results of the INTERCEPT-AD study in future to advance ACU193 to a Phase 2/3 clinical study.