Acumen Pharmaceuticals, Inc. has announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison study.

The study plans to compare the PK between subcutaneous and intravenous administrations of sabirnetug in healthy volunteers.

Acumen’s subcutaneous formulation of sabirnetug is co-formulated with Halozyme’s proprietary ENHANZE drug delivery technology (recombinant human hyaluronidase enzyme, rHuPH20) that enables large volumes of subcutaneous injection with increased dispersion and absorption of co-administered therapies. ENHANZE has been commercially validated in eight approved therapies.

“With a subcutaneous formulation of sabirnetug, we aim to provide a more convenient and accessible option for patients with Alzheimer’s disease, which we believe will improve treatment adherence through enhanced flexibility for patients, caregivers and providers,” said Daniel O’Connell, Chief Executive Officer of Acumen.

“We are strongly committed to advancing the underlying science and innovation of Alzheimer’s disease treatments, and we are excited about the potential of sabirnetug to make a meaningful impact on the lives of patients and their families,” he added.

Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in AD patients. Soluble AβOs are a highly toxic form of Aβ that begin to accumulate before a clinical diagnosis of AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration.

Acumen is developing sabirnetug as a potential next-generation antibody treatment for early AD. The company is currently enrolling patients in the ALTITUDE-AD study, a Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of intravenous sabirnetug in patients with early AD.

Topline results from the Phase 1 clinical trial INTERCEPT-AD indicated that intravenous administration of sabirnetug is well tolerated with a favorable overall safety profile, including low overall rates of ARIA-E.

The trial showed compelling improvement of downstream biochemical biomarkers, evidence of target engagement supporting proof of mechanism, and statistically significant amyloid plaque reduction comparable to approved amyloid-directed therapies at similar time points.