Pharma Focus Europe

AC Immune Granted FDA Fast Track Designation for ACI-24.060, an Anti-amyloid-beta Active Immunotherapy, in the Treatment of Alzheimer's Disease

Wednesday, June 28, 2023

AC Immune SA, a biopharmaceutical company specializing in precision medicine for neurodegenerative diseases, has announced that its anti-amyloid beta (Abeta) active immunotherapy candidate, ACI-24.060, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's disease (AD). This designation allows for expedited development and regulatory review of the drug. AC Immune aims to target toxic forms of Abeta with ACI-24.060, which is designed to induce a polyclonal antibody response against these toxic species.

The FDA's clearance of the Investigational New Drug (IND) application has also allowed for the expansion of the Phase 1b/2 ABATE study, which is investigating the safety and efficacy of ACI-24.060 in AD patients and individuals with Down syndrome (DS). The study has recently dosed its first individual with DS. The expansion of the study to the USA will accelerate its progress and provide additional data on safety and immunogenicity.

AC Immune plans to evaluate ACI-24.060's therapeutic potential by comparing the reduction of Abeta plaques achieved with the drug to those achieved with FDA-approved monoclonal antibodies. The company aims to generate early evidence of the vaccine's efficacy and support its further development as a next-generation therapy for AD and DS-related AD.

Individuals with DS are at a high risk for AD due to genetic factors, and AC Immune recognizes the need to address the specific requirements of this population. ACI-24.060 holds promise as a novel therapy that may lower Abeta plaques and delay or prevent the onset of clinical dementia symptoms in AD and DS-related AD. The company believes the vaccine offers advantages in safety, efficacy, and logistics over monoclonal antibodies, making it a valuable therapeutic option.

The ABATE study is a double-blind, randomized, placebo-controlled trial that assesses the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal AD and adults with DS. The trial includes a dose escalation phase in AD patients and evaluates various doses and dosing regimens. All participants must have confirmed brain Abeta pathology through positron emission tomography (PET) scans.

Individuals with DS have an overproduction of amyloid-precursor protein (APP), leading to the accumulation of Abeta plaques. DS-related AD shares similarities with other forms of genetic AD, making the study of ACI-24.060 in DS patients crucial for understanding its therapeutic potential in modulating neurodegeneration and providing a much-needed treatment option for this population.

ACI-24.060, derived from AC Immune's SupraAntigen platform, has demonstrated the ability to induce a strong polyclonal antibody response against oligomeric and pyroglutamate-Abeta species, which are key pathological forms of Abeta. The drug is designed to enhance the formation of broad-spectrum protective antibodies and has shown safety and tolerability in previous Phase 1 and 2 trials. ACI-24.060 has the potential to inhibit plaque formation, increase plaque clearance, and potentially reduce or prevent disease progression in AD. The company aims to demonstrate the drug's effect on amyloid plaque reduction, a surrogate marker for disease modification, in the first half of 2024.

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