Arialys Therapeutics Announces First Participants Dosed in a Phase 1 Clinical Trial of ART5803, a Precision Medicine for the Treatment of Autoimmune Neuropsychiatric Diseases

• ART5803 is being developed for the treatment of anti-NMDAR autoimmune neuropsychiatric diseases, including anti-NMDAR encephalitis (ANRE)
• Preclinical data in higher animal models confirms ART5803’s therapeutic potential for rapid reversal of anti-NMDAR autoantibody pathogenicity
• Safety and pharmacokinetic data from healthy volunteers anticipated in the first half of 2025

Excerpt from the Press Release:

LA JOLLA, Calif.–(BUSINESS WIRE)–Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatry, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ART5803. ART5803 is a therapeutic monoclonal antibody candidate designed to specifically compete with pathogenic autoantibodies targeting the NMDA receptor (NMDAR). Pathogenic anti-NMDAR autoantibodies cause anti-NMDAR encephalitis (ANRE), a devastating and underserved rare disease for which there is currently no approved therapy. Recent findings have also implicated anti-NMDAR autoantibodies in other neuropsychiatric diseases such as schizophrenia and dementia. Arialys anticipates initiating a Phase 2a proof of concept clinical evaluation of ART5803 in ANRE in the second half of 2025.

“ART5803 is a first-in-class precision therapeutic candidate and initiation of its clinical development is an important and exciting step towards the effective treatment of anti-NMDAR autoimmune neuropsychiatric diseases,” said Peter Flynn, Ph.D., President and CEO of Arialys Therapeutics. “In parallel to our clinical development efforts in ANRE, we are evaluating autoantibody levels and ART5803’s therapeutic potential in patients suffering from a broader set of neuropsychiatric diseases such as schizophrenia and dementia.”

The ART5803 Phase 1 clinical study is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers (ClinicalTrials.gov Identifier: NCT06575153). The study is being conducted in collaboration with Nucleus Network in Melbourne, Australia. The study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ART5803 and is expected to enroll approximately 40 subjects.

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