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Autoimmune Neuro Disease Start-Up Raises $58M

Mental health graphic

(Gordon Johnson, Pixabay.

12 Sept. 2023. A new company developing treatments for neurological and psychiatric diseases from aberrant immune system activity is raising $58 million in seed funds. Arialys Therapeutics in La Jolla, California is a one year-old enterprise founded by former researchers at Astellas Pharma Inc. in Tokyo, and advancing a therapy acquired from that company.

Arialys Therapeutics addresses autoimmune disorders in the central nervous system, where the immune system mistakes healthy cells and tissue for invading pathogens. The company’s lead product, code-named ART5803, is designed to block autoimmune antibodies causing a form of encephalitis or swelling of the brain. The disorder, called anti-NMDA receptor encephalitis, is caused by aberrant antibodies attacking N-methyl-D-aspartate or NMDA receptor proteins in the synapses or signaling components of neurons in the brain. While anti-NMDA receptor encephalitis is the most common form of autoimmune encephalitis, it’s still a rare disease, and according to Arialys, poorly managed and often misdiagnosed.

Reverses mental and motor abnormalities

ART5803, says Arialys, is designed to block the autoimmune antibodies responsible for anti-NMDA receptor encephalitis or ANRE. The treatment is a synthetic protein resembling an immunoglobulin G antibody that binds to a specific epitope or binding site in the aberrant autoimmune antibody to block its activity in the central nervous system or CNS. In a paper for the American Academy of Neurology annual meeting in April 2023, Arialys Therapeutics co-founder and chief scientist Mitsuyuki Matsumoto reported on preclinical research showing in lab cultures ART5803 binds to autoimmune antibodies from ANRE patients. In further tests with marmoset primates induced with ANRE, infusions of ART5803 reverse mental and motor abnormalities caused by the autoimmune antibodies within two weeks.

Arialys says the Food and Drug Administration assigned orphan drug status to ART5803, which the company calls a precision medicine for treating neurological and psychiatric disorders. “Precision medicine approaches have led to tremendous successes in oncology,” says Matsumoto in a Arialys Therapeutics statement, “and now we have the insights to be at the forefront of developing precision medicines to transform the treatment landscape for neuropsychiatry.” Matsumoto adds that the company plans “to file an IND next year and advance ART5803 into the clinic for the treatment of ANRE and autoimmune psychosis.” An investigational new drug application or IND is, in effect, a request to FDA to begin clinical trials.

Arialys Therapeutics is raising $58 million in seed funds from life science investors Avalon BioVentures, Catalys Pacific, MPM BioImpact, Johnson & Johnson Innovation, and Alexandria Venture Investments, with the proceeds aimed at expanding its portfolio to other CNS autoimmune diseases. The company is currently located at the Avalon BioVentures accelerator in La Jolla, with Jay Lichter, managing partner at Avalon BioVentures, serving as president and CEO of Arialys.”With the ability to isolate and characterize pathogenic autoantibodies in the CNS,” notes Lichter, “we can now develop novel therapeutics and diagnostics to help millions of people who suffer from neuropsychiatric disorders driven by autoimmune disease.”

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Disclosure: The author owns shares in Johnson & Johnson.

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