FDA Grants Adicet Bio’s ADI-001 Fast Track Designation for SLE Treatment

February 5, 2025

DENVER, Colo., Feb 05, 2025 (247marketnews.com)- Adicet Bio (NASDAQ:ACET) stated that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. Fast Track Designation is designed to accelerate the development and review process for drugs intended to treat serious conditions and address unmet medical needs.

ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20, currently being developed for various autoimmune diseases. The therapy has already received Fast Track Designation for treating relapsed/refractory lupus nephritis (LN) and SLE with extrarenal involvement. The company is advancing ADI-001 across six autoimmune indications, with patient enrollment ongoing for the Phase 1 trial evaluating ADI-001 for LN. Enrollment for SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS) is expected to begin in Q1 2025, with enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) to follow in the second half of 2025. In the Phase 1 GLEAN trial, ADI-001 demonstrated robust targeting of B-cells, complete depletion of CD19+ B-cells in peripheral blood and lymphoid tissue, showing promising results for treating autoimmune conditions.

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