Araclon Biotech, a subsidiary of Grifols, has unveiled promising early evidence regarding the effectiveness of its Alzheimer’s disease vaccine. In an exploratory analysis of phase 2 data, the Spanish biotech reported a noteworthy 38% reduction in disease progression compared to a placebo.
The data was presented at the 2023 Clinical Trials on Alzheimer’s Disease conference, where Araclon shared the results of a phase 2 clinical trial involving their vaccine candidate, ABvac40. In this trial, 134 patients with amnestic mild cognitive impairment or very mild Alzheimer’s were randomly assigned to receive either ABvac40 or a placebo over a 24-month study period, which included a crossover extension.
“ABvac40 “slowed disease progression up to 38% compared with placebo as measured by the Mini-Mental State Examination score,” a common way of assessing cognitive impairment. The trial wasn’t powered for finding efficacy on the score. “We are pleased to report final positive results from the phase 2 study of ABvac40, including a robust immune response with some significant reduction in disease progression, all with a favorable safety profile. The results reported for ABvac40 to date validate its clinical potential. We look forward to evaluating next steps for this program.”
– Jose Terencio, Ph.D., CEO, Araclon
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ABvac40 operates as an active vaccine targeting Aβ40, a peptide associated with plaques and vascular deposits linked to early-onset dementia. Earlier attempts at Alzheimer’s vaccine development, such as Elan Pharmaceuticals’ AN1792, were halted in phase 2 due to patients developing meningoencephalitis. However, Araclon has taken a different approach to address safety concerns by eliminating the epitope recognized by T cells in its candidate.
Over the past year, Araclon has been diligently addressing safety issues that plagued AN1792. They presented phase 2 data in late 2022 and continued with the findings of a crossover extension in early 2023, demonstrating a lack of meningoencephalomyelitis or ARIA-E (brain swelling associated with other Alzheimer’s drugs) in recipients of the vaccine candidate. The rates of ARIA-H, related to cerebral microhemorrhages, were similar in both the vaccine and placebo groups.
These final results provide further confirmation of the vaccine candidate’s safety profile. It’s worth noting that Araclon is yet to conduct a trial as extensive as the Elan study where AN1792 faced safety challenges, with 18 of the 300 immunized patients developing meningoencephalitis. The positive trajectory of ABvac40 offers hope in the ongoing quest to combat Alzheimer’s disease.
