Adicet Bio (NASDAQ: ACET) has announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory rheumatoid arthritis (RA).
The company’s Phase 1 study is designed to evaluate the safety, tolerability and preliminary efficacy of ADI-001 in patients with treatment-refractory RA. ADI-001 was granted fast track designation by the FDA for the potential treatment of relapsed/refractory class III or class IV LN, refractory systemic lupus erythematosus with extrarenal involvement, and systemic sclerosis.
In a statement, Julie Maltzman, MD, CMO of Adicet, commented, “Dosing the first patient in our clinical study of ADI-001 in treatment-refractory RA marks an important milestone in our Phase 1 program, which is now enrolling across seven autoimmune conditions. In this study we are evaluating two conditioning regimens, cyclophosphamide alone and in combination with fludarabine, to explore how different conditioning regimens may impact the overall therapeutic experience. Following the recent promising safety and efficacy results of ADI-001 in lupus nephritis and systemic lupus erythematosus, we are further encouraged about the potential of ADI-001 to transform outcomes across a range of autoimmune conditions.”
