Grifols mulling next steps for Alzheimer's vaccine after Phase II readout
25 Oct 2023
Clinical ResultPhase 2Vaccine
Grifols announced that its experimental ABvac40 vaccine achieved the primary endpoints of a Phase II study, confirming the jab's safety, tolerability and immune response in early-stage Alzheimer's disease patients. The findings were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference.
"Previous vaccines in development for Alzheimer's disease faced setbacks due to harmful meningoencephalitis side effects," remarked Jose Terencio, chief executive of Grifols' Araclon Biotech subsidiary, adding "we look forward to evaluating next steps for this programme."
The study included 134 patients with amnestic mild cognitive impairment or very mild Alzheimer's disease. In Part-A, patients were randomised to receive a total of six doses, including one monthly single-dose injection of ABvac40 or placebo for the first five months, followed by a booster of ABvac40 or placebo at month 10. Part-B was an extension study with cross-over from Part-A, in which placebo patients in Part-A received ABvac40, while ABvac40-treated patients received placebo and a booster of ABvac40.
Hints of cognitive benefit
GrifolsGrifols reported that ABvac40 induced a "robust immune response" against Aβ40 peptide, and also demonstrated "some potential cognitive benefits" in early-stage Alzheimer's patients, meeting the study's primary endpoints. The trial was not powered for finding efficacy on neuropsychological scales, although the company noted that the ABvac40-treated group saw as much as a 38% reduction in disease progression, based on the Mini-Mental State Examination (MMSE) score, suggesting ABvac40 could have "potential efficacy in addressing the cognitive decline" associated with the disease.
Other neuropsychological tests, known as RBANS and TMT, which evaluate things like memory, visual scanning, language and attention, also showed "favourable results" with ABvac40 versus placebo, Grifols said, while the vaccine was associated with a smaller increase in whole-brain atrophy as well. However, the company indicated that "global or functional scales did not show differences" between the two groups.
ABvac40 is designed to target the C-terminal end of the Aβ40 peptide, which Grifols says could help avoid immune triggers responsible for meningoencephalitis, a complication seen in earlier vaccines. Emerging research also suggests that Αβ40 plays a role in cerebral amyloid angiopathy (CAA), the company noted.
According to GrifolsGrifols, data presented at CTAD confirm preliminary findings indicating a comparable safety profile between ABvac40 and placebo, with similar rates of treatment-emergent adverse events. Further, there were no reports of cerebral oedema or aseptic meningo-encephalo-myelitis in the study, and "few instances" of micro-haemorrhages, with none leading to discontinuation, the company said.
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