Adicet Bio announces FDA clearance of ADI-001 IND amendment

Adicet Bio announced that the FDA has agreed to an amendment to the company’s investigational new drug, or IND, application to evaluate ADI-001 in idiopathic inflammatory myopathy, or IIM, and stiff person syndrome, or SPS, as part of the ongoing Phase 1 trial in autoimmune diseases. The company plans to initiate enrollment for IIM and SPS patients in the first quarter of 2025. This announcement follows the FDA’s recent agreements on amendments to the company’s ADI-001 IND application to evaluate three additional indications beyond lupus nephritis, or LN, including systemic lupus erythematosus, or SLE, systemic sclerosis, or SSc, and anti-neutrophil cytoplasmic autoantibody, or ANCA-associated vasculitis.