Araclon Biotech of Spain revealed positive data from the first part of a phase II trial for its immunotherapeutic vaccine to prevent Alzheimer’s disease- ABvac40.
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Araclon Biotech of Spain revealed positive data from the first part of a phase II trial for its immunotherapeutic vaccine to prevent Alzheimer’s disease - ABvac40. The data indicates that there is potential to slow the progression in those diagnosed with the debilitating neurodegenerative disease.
This phase II trial for ABvac40 was conducted in 21 locations across Europe. The trial design includes 124 patients diagnosed with either a very mild case of Alzheimer’s disease or mild cognitive impairment, with half of each category assigned to a placebo regimen. By conducting a randomized, double-blind clinical trial with diverse patients from all over Europe, Araclon fortifies the credibility of its research.
Amyloid-beta 40 (Aβ40) protein presence is an early indicator of Alzheimer’s disease, and accumulation of the protein in the brain represents disease progression. Jose Terencio, Araclon’s CEO and VP of Innovation at Grifols, explained that the vaccine “induces a strong immune response characterized by the increase in anti-Aβ40 titers at the same time that Aβ40 levels rise in plasma.”
In addition to showing effectiveness in heightening immune response, patients tolerated the 6-dose regimen well, with minimal adverse reactions observed. These positive indicators are an extension of those seen in phase I trial results, which used a 3-dose regimen and induced a smaller immune response in the 24 participants. Phase I was intended to investigate safety alone, but nonetheless showed the strong promise of the ABvac40 vaccine as 84% of the patients involved showed an increase in immunity.
Secondary to the overall prevention of Aβ40 protein presence and accumulation, Araclon researchers hope to gain insight into how the vaccine affects a patient’s quality of life and influence Alzheimer’s biomarkers.
In addition to working to prevent the presence of Aβ40 proteins, Araclon has developed an assay for early detection of the proteins. The assay, named ABtest-MS, accurately detects and quantifies Aβ40 and amyloid-beta 42 (Aβ42) using mass spectrometry biotechnology. This would enable diagnostics as well as disease progression tracking to further understand the mechanisms associated with Alzheimer’s disease.
Due to medical findings that have shown that symptoms do not present clinically until amyloid-beta proteins have accumulated in the brain, early protein detection in plasma samples could be a significant step towards getting treatment to patients early. Thus far, Araclon has completed two studies- the Ace Healthy Brain Initiative and the El A4 study- into the accuracy of the ABtest-MS assay, yielding promising results.
Araclon intends to present the vaccine and diagnostic assay data at the 2022 International Conference on Alzheimer’s and Parkinson’s Diseases and neurological disorders this week, in their home country. The presentation of data is sure to reinvigorate the search for a better understanding of a disease that affects a large global population.
The company’s short-term pipeline includes a thorough analysis of ABtest-MS results gathered from over 5,000 patients, as well as continuing with the second part of their phase II clinical trial, part B, to investigate the safety and efficacy of the ABvac40 vaccine.
