ART5803 / Arialys Therap - LARVOL DELTA

Arialys Therapeutics Announces U.S. FDA Fast Track Designation for ART5803, the First Precision Therapeutic Candidate in Development for the Treatment of Anti-NMDA Receptor Encephalitis (Businesswire)

Fast track • Inflammation • Rare Diseases

ART5803 a novel clinical stage precision medicine to treat anti-NMDAR autoimmune neuropsychiatric diseases (APA 2026) - P1 | "Following additional safety and pharmacokinetic evaluation of the multiple ascending dose cohorts in the ongoing Phase 1 trial, Phase 2 clinical trials in patients with ANRE and anti-NMDAR autoimmune neuropsychiatric diseases are planned for the second half of 2025. Emerging data highlights the potential therapeutic application of ART5803 in patients diagnosed with a variety of psychiatric disorders that are also positive for anti-NMDAR autoantibodies."

Clinical • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Dementia • Depression • Immunology • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Arialys Australia Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology • Mental Retardation • Psychiatry

A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Arialys Australia Pty Ltd | Trial completion date: Mar 2027 ➔ May 2028 | Initiation date: Aug 2025 ➔ May 2026 | Trial primary completion date: Dec 2026 ➔ Nov 2027

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Immunology • Mental Retardation • Psychiatry

Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Arialys Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Aug 2025

Trial completion • Trial completion date • CNS Disorders • Immunology

ART5803-101: Phase 1 Study of ART5803 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Arialys Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Oct 2025

First-in-human • Trial completion • Trial completion date • CNS Disorders • Immunology

ART5803, a First-in-class Precision Medicine to Treat Anti-NMDA Receptor Encephalitis, First-in-human Phase 1 Clinical Safety and Pharmacokinetic Profile (AAN 2026) - P1 | "Pharmacokinetic analysis suggests that IV doses above 30 mg/kg achieve therapeutic concentrations in ANRE patients allowing for dose and regimen selection for future studies. Phase 2 clinical assessments in ANRE and autoimmune psychosis patients are planned."

Clinical • First-in-human • P1 data • PK/PD data • CNS Disorders • Immunology • Rare Diseases

ART5803-101: Phase 1 Study of ART5803 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Arialys Therapeutics | Trial completion date: Sep 2025 ➔ Mar 2026 | Completed ➔ Active, not recruiting

Enrollment closed • First-in-human • Trial completion date • CNS Disorders • Immunology

ART5803-101: Phase 1 Study of ART5803 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Arialys Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ Sep 2025

First-in-human • Trial completion • Trial completion date • CNS Disorders • Immunology

BLOOD BRAIN BARRIER PENETRATION OF ART5803, A FIRST IN-CLASS PRECISION MEDICINE TO TREAT ANTI-NMDA RECEPTOR ENCEPHALITIS, IN THE FIRST IN-HUMAN, PHASE 1 CLINICAL TRIAL (WCN 2025) - "After establishing additional safety and pharmacometrics in the multiple ascending dose cohorts in the ongoing Phase 1 trial, we plan on initiating phase 2 clinical trials in patients with ANRE in the second half of 2025."

Clinical • First-in-human • P1 data • CNS Disorders

Arialys Therapeutics…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). (Arialys Press Release) - "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. "

FDA event • Trial status • CNS Disorders • Immunology

ART5803-101: Phase 1 Study of ART5803 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Arialys Therapeutics | Trial completion date: Sep 2025 ➔ Apr 2026

Trial completion date • CNS Disorders • Immunology

A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Antibody-Associated Psychiatric Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Arialys Australia Pty Ltd

New P2 trial • CNS Disorders • Immunology • Mental Retardation • Psychiatry

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