Araclon Biotech Presents Positive Final Results from Phase 2 Clinical Study of ABvac40 Alzheimer’s Vaccine at CTAD

• Trial met primary endpoints, confirming vaccine’s safety, tolerability and robust immune response against the Aβ40 peptide in early-stage Alzheimer's patients
• ABvac40 treatment slowed disease progression up to 38% compared with placebo as measured by the Mini-Mental State Examination score
• Vaccine’s unique design offers a new approach to address growing need for effective Alzheimer’s treatments as the prevalence of Alzheimer’s disease is expected to double by the year 2050 in the U.S. alone¹

ZARAGOZA, Spain, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Araclon Biotech, a Grifols Group company dedicated to the research and development of therapies and diagnostic methods applied to neurodegenerative diseases, today announced encouraging final results from its Phase 2 trial (NCT03461276) of ABvac40, an active vaccine against the Aβ40 peptide, for the treatment of patients with early-stage Alzheimer's disease (AD). Araclon gave a late-breaking presentation at the 2023 Clinical Trials on Alzheimer's Disease (CTAD) conference.

Results show that ABvac40 had a favorable safety profile, elicited a robust immune response against Aβ40, and demonstrated some potential cognitive benefits in early-stage AD patients, meeting primary endpoints and showing differences between the vaccine- and placebo-treated groups in some secondary exploratory endpoints.

Data confirm preliminary findings indicating a comparable safety profile between ABvac40 and placebo groups, with similar rates of treatment-emergent adverse events. Specifically in the treatment group there were no reports of swelling (ARIA-E) or aseptic meningo-encephalo-myelitis, and few instances of micro-hemorrhages (ARIA-H) comparable to placebo and none leading to discontinuation.

ABvac40 is uniquely designed to target the C-terminal end of the Aβ40 peptide, thus believed to prevent harmful reactions and avoid immune triggers responsible for meningoencephalitis, a complication observed in earlier AD vaccines. Emerging research suggests that Αβ40 plays a role in cerebral amyloid angiopathy (CAA), a highly prevalent condition among the growing number of AD patients. According to estimates by the Alzheimer’s Association, the number of patients with Alzheimer’s disease is expected to double by the year 2050 in just the U.S., from 6.7 million in 2023.¹