Acumen announces first subject dosed in Phase 1 study of sabirnetug

Acumen Pharmaceuticals announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug in a Phase 1 pharmacokinetic 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 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. Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AbetaOs in AD patients. Soluble AbetaOs are a highly toxic form of Abeta 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.