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Adicet Bio Says US FDA Agrees to Add 2 Autoimmune Indications for ADI-001 Program
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Adicet Bio Says US FDA Agrees to Add 2 Autoimmune Indications for ADI-001 Program
Oct 17, 2024 1:39 PM

10:54 AM EDT, 10/16/2024 (MT Newswires) -- Adicet Bio ( ACET ) said Wednesday that the US Food and Drug Administration has agreed to an amendment to its investigational new drug application, adding idiopathic inflammatory myopathy and stiff person syndrome to a phase 1 study of ADI-001 in autoimmune diseases.

The company said it plans to start enrollment for people with idiopathic inflammatory myopathy and stiff person syndrome in Q1 2025.

The ADI-001 program now targets six autoimmune diseases, including lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody-associated vasculitis, the company said.

Adicet said it plans to report initial data from the phase 1 study in H1 2025.

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