Acumen Pharmaceuticals Begins Phase 1 Dosing of ACU193 for Early Alzheimer's

Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), based in Newton, Mass., has announced the beginning of dosing the first participant in a Phase 1 pharmacokinetic (PK) comparison study for a subcutaneous formulation of their experimental Alzheimer's disease (AD) treatment, sabirnetug (ACU193). This study will evaluate the PK profiles between subcutaneous and intravenous administration methods in healthy volunteers.

The subcutaneous version of sabirnetug utilizes Halozyme’s ENHANZE® drug delivery technology. ENHANZE® uses recombinant human hyaluronidase enzyme (rHuPH20) to enhance the dispersion and absorption of therapies injected subcutaneously, allowing for larger volumes to be administered quickly. This technology has been validated in eight approved therapies, offering potential improvements in patient convenience and treatment adherence.

Daniel O’Connell, CEO of Acumen, emphasized the company's commitment to advancing Alzheimer's treatment through innovative methods. He noted that the subcutaneous formulation could provide more flexibility and accessibility, potentially enhancing adherence to treatment plans for patients, caregivers, and healthcare providers.

Sabirnetug is a humanized monoclonal antibody specifically targeting soluble amyloid beta oligomers (AβOs), which are highly toxic forms of amyloid beta. AβOs accumulate early in AD and are believed to trigger synaptic dysfunction and neurodegeneration. Sabirnetug is being developed as a next-generation antibody treatment aimed at early-stage AD.

The Phase 1 INTERCEPT-AD clinical trial, which concluded recently, demonstrated that intravenous sabirnetug was well tolerated with a favorable safety profile and low incidence of ARIA-E. The trial also highlighted improvements in biomarkers, proof of mechanism, and noteworthy reductions in amyloid plaques, similar to other approved amyloid-targeting therapies.

Acumen is currently conducting the ALTITUDE-AD Phase 2 trial to assess the efficacy and safety of intravenous sabirnetug in early AD patients. This follows encouraging results from the Phase 1 trial, which enrolled 65 participants with early symptomatic AD. The INTERCEPT-AD study included single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts to evaluate safety, tolerability, pharmacokinetics (PK), and target engagement.

Halozyme's ENHANZE® Technology, based on the patented rHuPH20 enzyme, enhances subcutaneous delivery by overcoming traditional volume and delivery rate limitations of biologics. This technology allows some treatments, typically given intravenously, to be administered subcutaneously within minutes, potentially reducing the need for multiple injections.

Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in treatments for Alzheimer's disease. Their primary focus is on developing sabirnetug, which selectively targets toxic soluble amyloid beta oligomers (AβOs). These oligomers are considered early and persistent triggers of Alzheimer's disease pathology. The ongoing Phase 2 clinical trial ALTITUDE-AD aims to further investigate the potential benefits of sabirnetug in early symptomatic AD patients.

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