On 4 October, AC Immune announced the opening of new clinical sites for their ABATE Phase 1b/2 trial, which is assessing ACI-24.060 in participants with prodromal Alzheimer’s disease (AD) and individuals with Down Syndrome. The new sites are based in the UK and Spain, and are currently recruiting participants to the ongoing trial, with a first interim analysis expected by the end of the year. ACI-24.060 is a vaccine that induces a broad antibody response against toxic forms of the amyloid beta protein, which accumulates in the brain during the development of AD. Estimates suggest that over 50% of people with Down Syndrome (DS) will develop dementia due to AD as they age: by the age of 40, most people with DS have the amyloid plaques that characterise AD in their brains. With the potential to increase amyloid plaque clearance, ACI-24.060 may therefore be a useful treatment for both AD, and DS-related AD.
ABATE is an ongoing, two-part, multi-center and placebo-controlled Phase 1b/2 trial evaluating the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060, which is delivered via subcutaneous injection. The two-part design involves a first, dose-escalation phase in participants with mild cognitive impairment (MCI) due to AD, also known as prodromal AD. Upon identification of an optimal dose and dosing regimen, the trial will advance to an expansion phase with participants who have prodromal AD, and will also initiate recruitment of people with Down Syndrome who do not yet have symptoms of dementia. AC Immune expects to complete an interim analysis of the ABATE data by the end of 2022, which will inform the start of the second phase of the trial. In their press release, the company stated that they plan to submit an Investigational New Drug application to the US FDA in early 2023.
