Adicet Bio Shares Initial Safety And Efficacy Data From The First Seven Patients Dosed With ADI-001 In The Ongoing Phase 1 Study In Patients With Autoimmune Diseases

Author: Benzinga Newsdesk | October 07, 2025 05:51am

• Clinical data to date supports a potentially transformational approach to treating autoimmune diseases with an off-the-shelf, one-time therapy.
• As of the August 31, 2025 data cut-off date, all seven evaluable LN and SLE patients experienced rapid and sustained reductions in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician's Global Assessment (PGA) highlighting ADI-001's potential fordurable effect on a broad range of lupus symptoms.
• As of the August 31, 2025 data cut-off date, all five LN patients experienced improved renal function, including three complete renal responses and Definition Of Remission In Systemic lupus erythematosus (DORIS) remissions, and two partial renal responses, with all responses ongoing.
• Generally well tolerated with a favorable safety profile to date, supporting the potential for outpatient administration; no Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and no Grade 2 or higher Cytokine Release Syndrome (CRS) was observed.
• All patients discontinued immunosuppressants and either discontinued or tapered corticosteroids to physiological levels.
• Clear evidence of immune reset with subsequent emergence of naïve and previously undetected B cell repertoire following single treatment.
• Recent momentum has resulted in more than 25 clinical sites open for enrollment to date.
• Adicet plans to request a meeting with the U.S. Food and Drug Administration (FDA) in 1Q/2026 to inform Phase 2 pivotal trial design with a study anticipated to commence in 2Q/2026

Posted In: ACET