The US Food and Drug Administration (FDA) has awarded Fast Track designation to the biopharmaceutical company AC Immune, for its investigational immunotherapy ACI-24.060. ACI-24.060 is a liposome vaccine that is designed to elicit an immune response against the toxic forms of amyloid beta proteins that build up in the brain during the development of Alzheimer’s disease. ACI-24.060 is currently being investigated in ABATE, a Phase 1b/2 double blind, randomised, placebo-controlled clinical trial in adults with mild cognitive impairment due to Alzheimer’s disease, and in adults with Down Syndrome. Individuals with Down Syndrome possess a third copy of the amyloid precursor protein (APP) gene, which is thought to cause the accumulation of amyloid plaques in the brain.
In a press release issued in January this year, the company announced interim safety, tolerability and immunogenicity results for ACI-24.060, explaining that the drug was generally safe, well tolerated, and could induce an antibody response two weeks after administration. The Fast Track designation is aimed at expediting the development and review of drugs to treat serious conditions and fill an unmet clinical need. Drugs that receive Fast Track designation may be eligible for more frequent meetings or communication with the FDA, and for accelerated approval and priority review, if relevant criteria are met. Initial PET scan data on amyloid plaque reduction by ACI-24.060 are expected in early 2024. Read the press release: