Arialys Raises $58M for Neuropsychiatric Disease Treatments

Arialys Therapeutics has secured $58 million in seed funding for the development of treatments targeting autoimmune neuropsychiatric diseases.

Arialys Raises $58M for Neuropsychiatric Disease Treatments

Arialys Therapeutics, a pioneering force in neurological advancements, has secured $58 million in seed funding for the development of treatments targeting autoimmune neuropsychiatric diseases.

Investors include the company’s founding backers, Avalon BioVentures, Catalys Pacific, and MPM BioImpact, alongside notable contributors Johnson & Johnson Innovation—JJDC, Inc. and Alexandria Venture Investments. The company, which officially launched in December 2021, has been working in stealth mode until now.

Arialys is focused on the development of ART5803, an antibody therapeutic aimed at treating anti-NMDA receptor encephalitis (ANRE), a prevalent form of autoimmune encephalitis.

ANRE is driven by crosslinking autoantibodies that induce the internalization of NMDA receptors, leading to seizures and psychosis in affected individuals. ART5803 is a single-arm antibody designed to bind to the same epitope as the NMDAR autoantibodies, preventing their binding.

Previously under the development of Astellas Pharma for ANRE treatment, Arialys acquired ART5803 in 2022. Promising preclinical studies were conducted on marmosets, demonstrating remarkable recovery within two weeks, a notably swift response for central nervous system drugs. Arialys has further substantiated these results in independent studies.

With this funding, Arialys intends to progress swiftly, planning to initiate trials with healthy volunteers in Q4 of 2024, followed by clinical testing in encephalitis patients in the first half of 2025. The company has received orphan drug designation from the FDA for ART5803 in treating ANRE. Additionally, Arialys has an ongoing internal discovery program focused on identifying various pathogenic autoantibodies and developing drugs to target them. A backup ANRE treatment with enhanced brain penetration is also in development.

Furthermore, the company is set to explore the potential of ART5803 in treating autoimmune psychosis, a condition where approximately 5% of schizophrenia patients exhibit autoantibodies against NMDA receptors. Research indicates similar autoantibodies are present in patients with conditions like dementia, bipolar disease, and severe depression, suggesting a broad range of applications for Arialys’ portfolio.

Jay Lichter, PhD, president and CEO of Arialys and managing partner of Avalon BioVentures, expressed, “Recent scientific discoveries have implicated abnormal autoimmune activity in a number of neuropsychiatric diseases, pointing us in a new direction to develop precision medicines for CNS disorders.”

He highlighted the paradigm shift in understanding immune system functions within the central nervous system, offering potential for innovative treatments for CNS-affecting autoimmune diseases like ANRE.

Autoimmune neuropsychiatric diseases represent a critical area of medical need, and Arialys Therapeutics stands poised to revolutionize treatment options with their groundbreaking approach and promising developments.