ART5803 / Arialys Therap - LARVOL DELTA

ART5803-101: Phase 1 Study of ART5803 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Arialys Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Immunology

Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Arialys Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Immunology

Monoclonal humanized monovalent antibody blocking therapy for anti-NMDA receptor encephalitis. (PubMed, Nat Commun) - "ART5803 ICV infusion or peripheral injections rapidly reversed these abnormalities. These data, together with the pharmacokinetic profile in cynomolgus monkeys, indicate a therapeutic potential for intravenous (IV)-administered ART5803 as a fast-acting and efficacious option for anti-NMDAR encephalitis."

Journal • CNS Disorders • Psychiatry

Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Arialys Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2025 ➔ Nov 2025

Enrollment open • Trial completion date • CNS Disorders • Immunology

IND-Enabling Safety Studies for ART5803, a Clinical-Stage Therapeutic One-Armed Antibody to Treat Anti-NMDA Receptor Encephalitis (S7.004). (PubMed, Neurology) - "Flynn has received personal compensation in the range of $500,000-$999,999 for serving as an officer or member of the Board of Directors for Arialys. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

Journal • CNS Disorders

IND-Enabling Safety Studies for ART5803, a Clinical-Stage Therapeutic One-Armed Antibody to Treat Anti-NMDA Receptor Encephalitis (AAN 2025) - "The data support clinical development of ART5803. After establishment of safety in Phase 1 clinical studies we plan on proof-of-concept clinical evaluation in human ANRE. Further, we are assessing the potential clinical development of ART5803 in a broader set of disease indications."

Clinical • CNS Disorders

Arialys Therapeutics Initiates MAD Cohorts Having Completed All Planned SAD Cohorts in a Phase 1 Study of ART5803 for the Treatment of Autoimmune Neuropsychiatric Disease (Businesswire) - "Arialys Therapeutics...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...'We look forward to further establishing the safety of ART5803 and transitioning to efficacy assessments later this year.'"

New P2 trial • P1 data • Trial status • Immunology • Rare Diseases

Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Arialys Therapeutics

New P1 trial • CNS Disorders • Immunology

ART5803-101: Phase 1 Study of ART5803 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Arialys Therapeutics | N=40 ➔ 64 | Trial primary completion date: Apr 2025 ➔ Sep 2025

Enrollment change • Trial primary completion date • CNS Disorders • Immunology

ART5803-101: Phase 1 Study of ART5803 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Arialys Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology

Phase 1 Study of ART5803 to Assess Safety and Tolerability in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Arialys Therapeutics

New P1 trial • CNS Disorders • Immunology

Peripherally Administered Therapeutic One-armed Antibody Reversed Behavioral Abnormalities in a Marmoset Model of Anti-NMDAR Encephalitis (AAN 2024) - "These data indicate a therapeutic potential for ART5803 as a faster acting, more efficacious, and safer treatment option for ANRE patients. PK and GLP toxicology studies in monkeys and rats are underway to support studies in humans."

CNS Disorders

Monoclonal Humanized One-Armed Antibody Blocking Therapy for Anti-NMDA Receptor Autoantibody-Mediated CNS Disorders (ACNP 2023) - "These data indicate a therapeutic potential for ART5803 as a faster acting, more efficacious, and safer treatment option for patients suffering from ANRE and other anti-NMDA receptor autoAb-mediated CNS disorders. Further studies are warranted to assess prevalence and significance of anti-NMDA receptor autoAbs in general neuropsychiatric disorders, such as psychosis, schizophrenia, bipolar disorder and depression. To this end, development of sensitive and selective standardized screening methods to detect autoAbs against NMDA receptor is currently underway at our laboratory."

Bipolar Disorder • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia • Tobacco Addiction

Monoclonal Humanized One-Armed Antibody Blocking Therapy for Anti-NMDA Receptor Autoantibody-Mediated CNS Disorders (ACNP 2023) - "These data indicate a therapeutic potential for ART5803 as a faster acting, more efficacious, and safer treatment option for patients suffering from ANRE and other anti-NMDA receptor autoAb-mediated CNS disorders. Further studies are warranted to assess prevalence and significance of anti-NMDA receptor autoAbs in general neuropsychiatric disorders, such as psychosis, schizophrenia, bipolar disorder and depression. To this end, development of sensitive and selective standardized screening methods to detect autoAbs against NMDA receptor is currently underway at our laboratory."

Bipolar Disorder • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia • Tobacco Addiction

Arialys Therapeutics Launches to Lead the Development of New Precision Medicines for Autoimmune Neuropsychiatric Diseases (Businesswire) - "Arialys Therapeutics, a biotechnology company pioneering new therapeutics for autoimmune neuropsychiatry, today announced the close of $58 million in seed financing....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....Arialys has received orphan drug designation from the U.S. Food and Drug Administration for ART5803 for the treatment of ANRE. Arialys purchased ART5803 from Astellas Pharma....Leveraging a depth of expertise and breakthrough scientific research, the team has already generated validating preclinical proof-of-concept data, and we are excited to file an IND next year and advance ART5803 into the clinic for the treatment of ANRE and autoimmune psychosis."

Financing • IND • Orphan drug • CNS Disorders • Immunology