Grifols’ Araclon Biotech presents ‘positive’ results from Phase 2 ABvac40 study

The company states: “Araclon Biotech, a Grifols Group company dedicated to the research and development of therapies and diagnostic methods applied to neurodegenerative diseases, announced encouraging final results from its Phase 2 trial of ABvac40, an active vaccine against the Abeta40 peptide, for the treatment of patients with early-stage Alzheimer’s disease. Araclon gave a late-breaking presentation at the 2023 Clinical Trials on Alzheimer’s Disease conference. Results show that ABvac40 had a favorable safety profile, elicited a robust immune response against Abeta40, 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 or aseptic meningo-encephalo-myelitis, and few instances of micro-hemorrhages comparable to placebo and none leading to discontinuation. ABvac40 is uniquely designed to target the C-terminal end of the Abeta40 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 undefinedbeta40 plays a role in cerebral amyloid angiopathy, 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.”