Adicet Bio’s ADI-001 shows positive preliminary Phase 1 results in LN and SLE

Adicet Bio (ACET) announced initial safety and efficacy data from the first seven patients dosed with ADI-001 in the ongoing Phase 1 study evaluating ADI-001 as a potential treatment for patients with autoimmune diseases Lupus Nephritis, or LN, and Systemic Lupus Erythematosus, or SLE. Based on these results, Adicet will request a meeting with the FDA to inform trial design for a potentially pivotal Phase 2 trial for LN, or for LN and SLE. Data highlights as of the August 31, 2025 cut-off date include: five LN patients and two SLE patients were evaluated with follow-up ranging from two to nine months; 100% of patients in the LN cohort achieved renal response, including three complete responses and DORIS remissions, and two partial responses, with all responses ongoing; 100% of patients saw rapid and sustained reductions in SLEDAI-2K and PGA scores, highlighting ADI-001’s potential durable effect on a broad range of lupus symptoms; ADI-001 demonstrated multiple hallmarks of an immune reset; ADI-001 was generally well tolerated and showed a favorable safety profile that could enable dosing in an outpatient setting. Across all seven patients dosed with ADI-001, there were no serious adverse events, and no reported cases of ICANS. Adicet plans to request a meeting with the FDA in 1Q26 to inform Phase 2 pivotal trial design with a study anticipated to commence in 2Q26.