Lu AF20513 is an investigational anti-beta-amyloid vaccine being developed by Lundbeck and Otsuka for the treatment of Alzheimer’s disease.

How Lu AF20513 works

Alzheimer’s disease is a neurological disorder in which the slow death of nerve cells in the brain results in a progressive decline of memory and the ability to process and store information. One cause of the disease is thought to be the clumping and building up of beta-amyloid peptide into plaques, which possibly blocks cell-to-cell communication and activates immune system cells that trigger inflammation.

Lu AF20513 vaccine consists of engineered mixed-peptides (protein pieces) with repeats of the first 12 amino acids of beta-amyloid and sequences of tetanus toxin. The aim of this strategy is to stimulate a population of immune cells called T-cells, originally generated by childhood tetanus vaccinations. These T-cells will then trigger the production of another type of immune cells, called T-helper cells, which in turn will induce a B-cell response to produce antibodies against beta-amyloid.

This is expected to have both therapeutic and preventive potential in Alzheimer’s symptoms.

Lu AF20513 in clinical trials

Lu AF20513’s immunogenicity (the ability to trigger an immune response), efficacy, and safety were first assessed in preclinical studies performed in mice, guinea pigs, and monkeys. Researchers verified that the therapy induced a robust production of anti-beta-amyloid antibodies that reduced Alzheimer’s-like disease in the animals’ brains.

The results of these studies were published in The Journal of Neuroscience and supported the vaccine’s testing in Phase 1/2a clinical trials.

Lundbeck and Otsuka initiated a Phase 1 trial (NCT02388152) in patients with mild Alzheimer’s disease in 2015. The trial was designed to evaluate the administration of either low, medium, or high doses of the vaccine to participants and assess its safety and tolerability. The study is still active but no longer recruiting participants.

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