Arialys
Precision Medicines for Autoimmune Neuropsychiatric Diseases
Historically, people thought that the central nervous system (CNS) is immune privileged—meaning the CNS has no immune cells or immune action. But in the last five years, about a dozen scientific studies have shown that this is not true, and the CNS has not only B and T cells, but also autoantibodies. Arialys was founded on this breakthrough understanding that immune cells—not only in the body’s periphery but especially in the brain—can produce autoantibodies that cause severe neurological and psychiatric diseases.
An example is anti-NMDA receptor encephalitis (ANRE), one of the most common forms of autoimmune encephalitis. ANRE is a rare, potentially lethal, and poorly managed neurological disease because it is often misdiagnosed. ANRE is caused by autoantibodies that crosslink and drive internalization of NMDA receptors (NMDAR) in the brain, resulting in psychosis. Arialys’ lead therapeutic, ART5803, is a therapeutic antibody designed to treat ANRE by blocking NMDAR autoantibodies. The pathogenic antibodies that cause ANRE are two-armed, each of them binds one NMDAR crossing two NMDARs that internalize. ART5803 was designed as a single-arm antibody that binds to an NMDAR blocking the pathogenic autoantibody from binding to it.
ART5803 was initially developed by Astellas Pharma, and Arialys was founded in 2021 by Avalon BioVentures, Catalys Pacific, and MPM BioImpact, and acquired the asset from Astellas. Arialys has received Orphan Drug Status for their lead candidate and expects to file an Investigational New Drug (IND) application next year. They expect to dose healthy volunteers in 2024 and to dose the first ANRE patient in 2025.
