Acumen Pharmaceuticals Presents Positive Topline Results from First-in-Human Phase 1 Study of ACU193 for Early Alzheimer’s Disease at the Alzheimer’s Association International Conference (AAIC) 2023

• Topline results from INTERCEPT-AD trial met primary and secondary objectives, demonstrating proof-of-mechanism for ACU193, the first clinical-stage amyloid beta oligomer (AβO)-targeting antibody

• Rapid, dose-related, statistically significant (p=0.01) amyloid plaque reduction observed within higher dose cohorts (25% reduction in 60 mg/kg Q4W cohort at day 63 and 20% reduction in 25 mg/kg Q2W cohort at day 70)
  
• ACU193 approached maximal central target engagement of toxic AβOs beyond expected levels, establishing broad therapeutic index and path to convenient monthly dosing ​
  
• ACU193 was well-tolerated in patients with early Alzheimer’s disease and resulted in no drug-related serious adverse events, with a low rate of ARIA-E across all cohorts
  
• Company to host conference call and webcast for investors and analysts July 17 at 8 a.m. ET
  

CHARLOTTESVILLE, Va. and CARMEL, Ind., July 16, 2023 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today presented positive topline results from the Phase 1 INTERCEPT-AD trial of ACU193, the first clinical-stage AβO targeting antibody therapy in early AD, at the Alzheimer’s Association International Conference (AAIC) 2023, taking place in Amsterdam and online from July 16-20, 2023.

Topline results demonstrated that ACU193 was generally well-tolerated with a compelling overall safety profile, meeting the primary objective of this Phase 1, first-in-human, randomized, double-blind, placebo-controlled study in both single and multiple doses in 60 participants with early AD. Dose levels were 2, 10, 25 and 60 mg/kg for one to three doses administered intravenously. An analysis of change in amyloid plaque load, as measured by positron emission tomography (PET) SUVr, demonstrated a rapid, dose-related mean decrease at the higher dose levels studied (60 mg/kg every 4 weeks [Q4W] and 25 mg/kg every 2 weeks [Q2W]). This finding is comparable to mean amyloid plaque decreases of approved Aß monoclonal antibodies at similar time points in their clinical development. The overall rate of amyloid related imaging abnormalities – edema (ARIA-E) was 10.4%, which included one case of symptomatic ARIA-E (2.1%). Pharmacokinetic results in serum and cerebrospinal fluid (CSF) demonstrated statistically significant dose proportionality and support monthly dosing of ACU193. Statistically significant, dose-related central target engagement was observed as measured by ACU193-AßO complex, establishing the first target engagement assay developed that is specific to an AßO-targeting antibody. An exposure response relationship (Emax) model revealed near maximal target engagement with repeated dosing at 25 mg/kg and 60 mg/kg.