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.
