预约演示
Araclon vaccine appears to slow Alzheimer's in exploratory phase 2 analysis, spurring review of next steps
2023-10-25
临床结果临床2期疫苗
The final data for Araclon Biotech's Alzheimer’s disease vaccine confirm the absence of meningoencephalomyelitis or ARIA-E.
Araclon Biotech hasAraclon Biotech evAlzheimer’s diseaseheimer’s disease vaccine is effective, linking the candidate to a 38% slowdown in disease progression compared to placebo in an exploratory analysis of phase 2 data.
Araclon Biotechtech, which is part of Grifols, reportAlzheimer’s disease vaccineAlzheimer’s diseasea phase 2 clinical trial of its vaccine candidate ABvac40 in a late-breaking presentation at the 2023 Clinical Trials on Alzheimer's Disease conference. Investigators randomized 134 patients with amnestic mild cognitive impairment or very mild Alzheimer’s to receive ABvac40 or placebo across a 24-month study and crossover extension.
ABvac40 “slowed disease progression upGrifols compared with placebo as measured by the Mini-Mental State Examination scoreABvac40mmon way of assessing cognitive impairment. The trial wasn’t powAlzheimer's Diseaseficacy on the score, but, in a press release, Araclon saamnestic mild cognitive impairmentABvac40
ABvac40 pleased to report final positive results from the phase 2 study of ABvac40, including a robust immune response with some significant reduction cognitive impairmenton, all with a favorable safety profile,” Araclon CEO Jose Terencio, Ph.D., said in a sAraclont. “The results reported for ABvac40 to date validate its clinical potential. We look forward to evaluating next steps for this program.”
ABvac40 is an active vaccine against Aβ40, a peptide found in plaques and vABvac40 deposits that is linked to earlier onset of dementia. Work on a previous Alzheimer’s vaccine candidate, Elan Pharmaceuticals’ AN17Araclonpped in phase 2 after patients developed meningoencephalitis. But Araclon ABvac40ed to step around that safety problem by eliminating the epitope recognized by T cells from its candidate.
ABvac40e past 12 months, Araclon has begun to make the case that it has addressed the safety concerns that torpedoed AN1792, prdementia top-line phase 2 datAlzheimer’s vaccinefollowing upElan PharmaceuticalsPDAN1792a crossover extension earlier this year. No pameningoencephalitisningoeAraclonomyelitis or ARIA-E—brain swelling associated with other Alzheimer’s drugs—in the crossover extension. The rates of ARIA-H, a term for cerebral microhemorrhages, were similar in the vaccine and placebo group.
The final data confirm thAraclonce of meningoencephalomyelitis or ARIA-E in recipients of the vaccine candidate. A caveat to the positive safety result is that Araclon is yet to run a trial as big as the Elan study that killed off AN1792. In that trial, 18 of the 300 immunized patients developed meningoencephalibrain swelling
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