Acumen Pharmaceuticals has announced updated data for its ACU193 in phase I INTERCEPT-AD trial to treat Alzheimer’s disease.
The news was announced as part of the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston and the US-based company has said that it plans to progress to a phase II/III clinical study, with the phase II portion planned for the first half of 2024.
The trial investigating ACU193 sought to demonstrate that the therapy was well-tolerated with a compelling overall safety profile in both single- and multiple-dose regimens administered to a cohort of 62 participants with early-stage Alzheimer’s disease (AD).
The INTERCEPT-AD trial sought to target toxic soluble amyloid beta oligomers (AβOs) that are key in the development of AD. Now, researchers have said that ACU193 approached maximal central target engagement of AβOs beyond expected levels.
Daniel O’Connell, president of Acumen, said: “The robust Phase 1 dataset not only validates our confidence in ACU193 as a differentiated amyloid-directed therapy with a novel target but also offers crucial insights that have helped shape the next phase of the study, during which we look forward to evaluating ACU193 in early AD patients over a longer-term period to assess clinical efficacy.”
Acumen has also said that the results demonstrated dose-related plaque reduction, low overall rate of amyloid related imaging abnormalities (ARIA-E) and consistent dose-related pharmacokinetics (PK) results supporting dosing of ACU193 every four weeks, in turn confirming proof-of-mechanism for the first clinical-stage monoclonal antibody designed to selectively bind to soluble amyloid beta oligomers.
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The report follows Acumen’s announcement in July that it had successfully met its primary and secondary endpoints in significantly reducing amyloid plaque load.
Eric Siemers, chief medical officer of Acumen, said: “Following ACU193’s significant target engagement of AβOs, as determined by our novel assay designed to detect this difficult-to-quantify species of Aβ, I am pleased with the data modelling of the exposure-response relationship, or Emax curve, for target engagement that allowed us to select the two doses for the next phase of study.”
According to GlobalData, the general US market for AD-related treatment presently sits at around $2,623m, with the market expected to grow to $9,553m by 2028.
GlobalData is the parent company of Clinical Trials Arena.