The results of the phase II trial support continuing with the clinical development of the active vaccine against peptide A40 for the treatment of Alzheimer’s disease (AD) in the early phase, called ABvac40 and from Aragon’s Araclon Biotechfrom the Grifols Group.
This study has not only confirmed the safety, tolerability and strong immune response of what could become the first Spanish vaccine against this growing neurological disease but has also slowed the progression of the disorder by up to 38%, compared to placebo. By specifically targeting the amyloid peptide A40, ABvac40 is harnessing a central mechanism, thought to drive cognitive decline, with potential to alter the course of the disease.
According to information from Araclon Biotech about this trial (multicenter, randomized, double-blind and placebo-controlled, and carried out in 23 centers in the European Union), no cases of inflammation or aseptic meningoencephalomyelitis were reported in the treatment group, and there were few cases of microbleeds, comparable to placebo, and none that led to treatment discontinuation.
Other relevant results of phase II are that the neuropsychological tests, such as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) or the Trial Performance Test (TMT), showed favorable results in ABvac40 compared to the placebo group. The global or functional scales showed no differences between the two groups. And with volumetric MRI, an increase in brain atrophy was observed in the ABvac40 group compared to placebo.
Mercè Boada, medical director of the Ace Alzheimer Center in Barcelona and principal investigator of the phase II study, highlighted to this newspaper that the safety of this vaccine “is fantastic”, and that there has been no “nor aseptic meningoencephalomyelitis“. And he assured that “the immune response is very important; It drops when the vaccine is stopped, but after 10 months it is separated from the placebo and, with the booster dose, the peak response is very high and is maintained until almost 24 months. That indicates that it is immunizing.” He also pointed out that there is still find the most appropriate dose and in what period the recall would have to be done to maintain immunity.