In a late-breaking presentation at the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) conference, researchers from Araclon Biotech shared positive results from their Phase 2 trial of ABvac40. According to these results, ABvac40 has a favourable safety profile, is able to induce a robust immune response, and may also have some potential cognitive benefits in early Alzheimer’s disease (AD).
ABvac40 is an investigational vaccine which targets an amyloid beta peptide called AB40. AB40 is one of the amyloid beta peptides that builds up in the brain during the development of AD, and is one of the main components of amyloid plaques. ABvac40 uses vaccine technology to “immunise” patients against AB40, stimulating them to produce antibodies that could help remove amyloid beta peptides from the brain.
Araclon Biotech launched its Phase 2 trial of ABvac40 in 2018, aiming to enrol 120 participants with mild cognitive impairment or very mild AD in Spain, France, Italy and Sweden. This multicenter, randomized, double-blind, placebo-controlled Phase 2 trial was divided into two parts with a total enrolment of 134 patients. Patients in the first part of the trial were randomized to receive a total of six doses: monthly injections of ABvac40 or placebo for 5 months, followed by a delayed booster of ABvac40 or placebo at month 10. The second part of the trial was an extension study with cross-over of treatment, in which placebo patients in the first part received ABvac40, and ABvac40-treated patients received placebo and a booster of ABvac40. Primary endpoints were immunogenicity, safety, and tolerability.
A final analysis of trial results showed that it had reached its primary endpoints, confirming vaccine safety, tolerability and a robust immune response against the AB40 peptide. Evaluation of neuropsychological test scores showed up to a 38% reduction in decline on the Mini-Mental State Examination score, pointing to a potentially beneficial effect on cognition. In their press release, the company also stated that they found favourable results on the RBANS and TMT scales, although no differences were found between placebo and treatment groups for the functional outcomes. Read the Araclon Biotech press release: