The US Food and Drug Administration (FDA) has granted fast track designation to AC Immune SA’s investigational anti-amyloid beta immunotherapy vaccine for Alzheimer’s disease.
The candidate, ACI-24.060, will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate the review of treatments for serious conditions.
The announcement follows the FDA clearance of the company’s investigational new drug (IND) application, allowing for the expansion to the US of the ongoing phase 1b/2 ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.
ACI-24.060’s fast track designation and IND clearance, as well as the expansion of ABATE to include individuals with Down’s syndrome, was supported by initial interim safety and immunogenicity results from the low dose cohort of the trial. Dosing in a second, higher dose cohort began earlier this year.
Dr Andrea Pfeifer, chief executive officer of AC Immune SA, said: “This regulatory progress underscores the attraction of an active immunotherapy targeting toxic species of anti-amyloid beta.”
“As ACI-24.060, created using our SupraAntigen platform, specifically targets the most toxic forms of anti-amyloid beta, 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,” Pfeifer added.
Those with Down’s syndrome have a third copy of all or part of chromosome 21, which contains the gene that codes for amyloid-precursor protein, and overproduction of this protein is believed to cause the accumulation of anti-amyloid beta plaques – a key hallmark of Alzheimer’s disease.
Given the more predictable onset and progression of symptoms in Down’s syndrome-related Alzheimer’s disease, AC Immune said it believes ABATE’s results will “offer crucial insights into the ability of ACI-24.060 active immunotherapy to modulate neurodegeneration at its earliest stages and offer this population a much needed therapeutic option”.
Dr Johannes Streffer, the company’s chief medical officer, said it remains “firmly on track” to report additional interim safety and immunogenicity data later this year and for the “crucial interim readout” of anti-amyloid beta-PET imaging data in the first half of 2024.
“By benchmarking the amount of anti-amyloid beta plaque reduction achieved with ACI-24.060 against those achieved with FDA-approved monoclonal antibodies, we believe we can generate early evidence of our vaccine’s therapeutic potential to support its expeditious advancement towards pivotal programmes in Alzheimer’s disease and Down’s syndrome-related Alzheimer’s disease,” Streffer said.