The vice president of Innovation and New Technologies at Grifols provided perspective on the interim phase 2 findings of ABvac40, a vaccine in development for patients with Alzheimer disease. [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"The safety profile is very similar to the placebo. We have not found any ARIA (amyloid-related imaging abnormalities)-edema and in the case of microhemorrhages, we found the same number between the placebo and the vaccine."
Alzheimer disease (AD), the leading cause of dementia in the elderly, is a neurodegenerative disorder believed to be due to the deposition of amyloid plaques and abnormal tau protein in the brain. The treatment paradigm for AD consists of cholinesterase inhibitors, N-methyl-D-aspartate receptor antagonists, and newer monoclonal antibodies against amyloid-ß like lecanemab (Leqembi; Eisai). While antiamyloid therapies have drawn a lot of attention, there are several in the field exploring primary preventive approaches, such as vaccines, to help reduce the burden of AD.
In a late-breaking poster presented at the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 24-27, in Boston, Massachusetts, Araclon Biotech, a Grifols Group company, presented preliminary findings from a phase 2 study (NCT03461276) assessing ABvac40, its investigational AD vaccine. All told, the ABvac40 group showed a 38% slowing of disease progression compared with placebo as evidenced by changes in Mini-Mental State Examination score starting at month 6, resulting in a statistically significant difference at month 12 (least square mean difference, 1.44; 95% CI, 0.18-2.69; P = .0252). In addition, RBANS scores favored the ABvac49 group from month 12, with maximal difference at month 18, although differences were not statistically significant.
Presented by Jose Terencio, PhD, the data demonstrated the proof of concept of ABvac40, which is designed to specifically target the amyloid-ß40, a key pathological feature associated with AD. Terencio, vice president of Innovation and New Technologies at Grifols, sat down with NeurologyLive® at the meeting to discuss the study in detail, how it was conducted, and the topline results the clinical community should key in on. Additionally, he spoke about the neuropsychiatric benefits observed with the vaccine, the its positive safety profile, and why it differs from traditional antiamyloid therapies that have amyloid-related imaging abnormalities associated with them.
1. Terencio J, Pascual-Lucas M, Lacosta AM, et al. Safety, immunogenicity, clinical efficacy and biomarkers of ABvac40, an active vaccine anti-Aß40 in patients with amnestic mild cognitive impairment or very mild Alzheimer’s disease: final results of a phase 2 randomized study. Presented at: Clinical Trials on Alzheimer’s Disease (CTAD) conference; October 24-27, 2023; POSTER LB04