Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement
Shots:
- The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement
- Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS) will start in Q1’25, with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) enrollment expected in H2’25
- The P-I (GLEAN) trial demonstrated robust exposure and complete CD19+ B-cell depletion as ADI-001 targets B-cells via an anti-CD20 CAR
Ref: Businesswire | Image: Adicet Bio
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