Anti-Abeta Vaccine Candidate Fast Tracked for Alzheimer Disease

The Food and Drug Administration (FDA) has granted Fast Track designation to ACI-24.060, an anti-amyloid beta (Abeta) active immunotherapy candidate for the treatment of Alzheimer disease.

By enhancing the formation of polyclonal anti-Abeta antibodies, ACI-24.060 is expected to inhibit plaque accumulation and increase plaque clearance, thereby potentially reducing or preventing Alzheimer disease progression.

The designation was supported by initial interim safety and immunogenicity data from the phase 1b/2 ABATE trial (ClinicalTrials.gov Identifier: NCT05462106), a double-blind, placebo-controlled study assessing ACI-24.060 in patients with prodromal Alzheimer disease.

Results showed that ACI-24.060 elicited an anti-Abeta antibody response in the low-dose cohort. Treatment was found to be safe and well tolerated with no serious safety concerns reported.

The anti-Abeta vaccine candidate is currently being investigated at a higher dose. Initial data on amyloid plaque reduction measured by PET imaging are expected in the first half of 2024.

“By inducing a polyclonal response including antibodies against both oligomeric Abeta and pyroglutamate-Abeta, ACI-24.060 targets the same toxic species as disease modifying anti-Abeta monoclonal antibodies that slowed AD progression in phase 3 clinical trials,” said Dr. Andrea Pfeifer, CEO of AC Immune SA. “As ACI-24.060, created using our SupraAntigen^® platform, specifically targets the most toxic forms of Abeta, we believe it may offer best-in-class efficacy with all the potential advantages in safety, administration and distribution that can be expected from a vaccine.”

The ABATE study will also assess the effects of ACI-24.060 in adults with Down syndrome.

This article originally appeared on MPR