October 7, 2025 — Leads & Copy —
Adicet Bio, Inc. (Nasdaq: ACET) has announced initial safety and efficacy data from the first seven patients dosed with ADI-001 in its Phase 1 study. This study evaluates ADI-001 as a potential treatment for autoimmune diseases. The data, which cut off on August 31, 2025, includes seven patients (five with lupus nephritis (LN) and two with systemic lupus erythematosus (SLE)), with follow-up ranging from two to nine months. Adicet plans to request a meeting with the FDA to discuss trial design for a potentially pivotal Phase 2 trial for LN, or for both LN and SLE.
According to Julie Maltzman, M.D., Chief Medical Officer of Adicet Bio, preliminary results show disease remissions or a halting of disease progression in all seven patients treated in the Phase 1 trial. All patients discontinued immunosuppressant medications and either discontinued or tapered corticosteroids after a single dose of ADI-001. ADI-001 demonstrated a favorable safety and tolerability profile with no ICANS, and only two patients experiencing Grade 1 CRS.
Chen Schor, President and Chief Executive Officer of Adicet Bio, noted that the observed evidence of immune reset and the potential for ADI-001 to transform the treatment landscape for autoimmune diseases. The company plans to engage with the FDA in the first quarter of 2026 to discuss the design of a potentially pivotal study, anticipated to begin in the second quarter of 2026.
Data highlights include 100% of LN patients achieving renal response, rapid and sustained reductions in SLEDAI-2K and PGA scores, and ADI-001 demonstrating multiple hallmarks of an immune reset. The company anticipates SLE and LN patient enrollment to continue in the ongoing Phase 1 study until the Phase 2 pivotal study is open for enrollment.
Contact:
Julie Maltzman, M.D., Chief Medical Officer of Adicet Bio
Source: Adicet Bio, Inc.
