Articles from Arialys Therapeutics

Arialys Therapeutics, a clinical-stage biotechnology company pioneering precision medicines for autoimmune neuropsychiatric diseases, today announced clinical and regulatory progress for ART5803, a novel therapeutic candidate designed using structural biology to specifically inhibit the pathogenic effects of autoantibodies that target the NMDA receptor.

Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatric diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to ART5803 for the treatment of pediatric patients with anti-NMDA receptor encephalitis (ANRE). ART5803 is a novel precision therapeutic candidate designed using structural biology to specifically inhibit the pathogenic effects of autoantibodies that target the NMDA receptor. Dosing of Phase 1 single- and multiple-ascending dose (SAD and MAD) studies in healthy volunteers has been completed, and Phase 2 evaluation in both ANRE and autoimmune psychosis patients is currently being initiated.

Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatric diseases, today announced the publication of preclinical data in Nature Communications demonstrating that its lead drug candidate, ART5803, effectively blocks the underlying disease mechanism in anti-NMDA receptor encephalitis (ANRE) and rapidly reverses behavioral symptoms in a non-human primate model. The findings support the continued clinical development of ART5803 as a first-in-class, targeted therapeutic. The company is currently completing Phase 1 safety studies for ART5803 and plans Phase 2 evaluation in anti-NMDA receptor encephalitis (ANRE) and autoimmune psychosis patients in the second half of 2025.

Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatry, today announced the completion of all five Single Ascending Dose (SAD) cohorts and the initiation of the Multiple Ascending Dose (MAD) cohorts in its ongoing double-blind, placebo-controlled, Phase 1 study of ART5803 in healthy volunteers. Phase 2 proof-of-concept studies in patients suffering from the rare and devastating disease, ANRE, are anticipated to start in the second half of 2025.

Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatry, today announced the appointment of Sankalp “Sam” Gokhale, M.D., as Chief Medical Officer. Dr. Gokhale is a U.S. board-certified neurologist with over 15 years of clinical practice and pharmaceutical industry experience. He has extensive expertise in all phases of clinical development, specifically in rare disease neurology indications.

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.

Arialys Therapeutics, a biotechnology company pioneering new precision medicines for autoimmune neuropsychiatry, today announced the appointment of Peter Flynn, Ph.D., as President and Chief Executive Officer. Dr. Flynn has more than 20 years of executive leadership experience in the biotech industry, from private start-ups to established publicly traded companies, scaling companies through key financings and pharma partnerships, advancing novel therapeutics from scientific breakthrough to the clinic, and commercializing FDA-approved medicines. In conjunction, Jay Lichter, Ph.D., Managing Partner of Avalon BioVentures and former President and CEO of Arialys, has been appointed Chair of the company’s Board of Directors.

Arialys Therapeutics, a biotechnology company pioneering new therapeutics for autoimmune neuropsychiatry, today announced the close of $58 million in seed financing. The investors in the financing included the company’s founding investors, Avalon BioVentures, Catalys Pacific, and MPM BioImpact, along with Johnson & Johnson Innovation – JJDC, Inc. and Alexandria Venture Investments. The proceeds of the financing will be used to advance new precision medicines that specifically block pathogenic autoantibodies in the central nervous system (CNS) and meaningfully expand the treatment possibilities for neuropsychiatric diseases driven by autoimmunity.