regulatory
confidence high
sentiment positive
materiality 0.60
Adicet Bio receives FDA clearance to evaluate ADI-001 in IIM and Stiff Person Syndrome
Adicet Bio, Inc.
- FDA cleared IND amendment for ADI-001 to treat idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS).
- Patient enrollment for IIM/SPS cohort expected to start Q1 2025; Phase 1 now covers six autoimmune diseases.
- Phase 1 program has four arms: LN/SLE, SSc, AAV, and combined IIM/SPS cohort.
- Initial clinical data from Phase 1 in autoimmune diseases expected first half of 2025.