Therapy Areas: Autoimmune
Adicet Bio receives FDA clearance to expand ADI-001 trials to additional autoimmune diseases
16 October 2024 -

Clinical stage biotechnology company Adicet Bio Inc (Nasdaq: ACET) announced on Wednesday that it has received FDA approval to amend its Investigational New Drug (IND) application to include idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) in its ongoing Phase 1 trial for ADI-001.

Patient enrollment for these cohorts is set to begin in the first quarter of 2025. ADI-001's clinical development now targets six autoimmune diseases, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).

Adicet plans to report initial data from its Phase 1 trial in the first half of 2025.

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