FDA Grants ADI-001 Fast Track Designation as Treatment of Refractory Systemic Lupus Erythematosus
ADI-001 is an investigation allogeneic gamma delta chimeric antigen receptor T cell therapy that targets CD20 for the treatment of a variety of autoimmune diseases.
ADI-001 is an investigation allogeneic gamma delta chimeric antigen receptor T cell therapy that targets CD20 for the treatment of a variety of autoimmune diseases.
There is no certain cause of lupus, but certain factors, such as genetics, hormones, and environment, could trigger lupus and various symptoms. | Image Credit: fizkes | stock.adobe.com
Previously, the drug was granted fast tract designation for the potential treatment of relapsed or refractory class III or class IV lupus nephritis. Following this designation, the first patient was dosed in a phase 1 clinical trial for lupus nephritis.2,3
“Dosing the first lupus nephritis patient in our phase 1 trial of ADI-001 marks an important step forward in our mission of improving the lives of patients affected by autoimmune diseases, particularly lupus nephritis,” Francesco Galimi, MD, PhD, senior vice president and chief medical officer of Adicet Bio, said in a news release. “With clinical biomarker data from our study in non-Hodgkin lymphoma demonstrating robust tissue trafficking and complete CD19+ B cell depletion in peripheral blood and secondary lymphoid tissue, ADI-001 has the potential to be a transformative off-the-shelf treatment option for several autoimmune diseases. Additionally, the FDA’s fast track designation to ADI-001 in relapsed/refractory class III or class IV [lupus nephritis] and the clearance of our investigational [investigational new drug application] amendment application of ADI-001 for the treatment of [stiff person syndrome] and [idiopathic inflammatory myopathy] further serves to emphasize the broad and urgent unmet need for approved therapies to address autoimmune diseases.”3
Lupus causes inflammation throughout the body, with symptoms ranging depending on where the autoimmune system damages tissue. This can include the skin, blood, joints, kidneys, brain, heart, and lung. SLE is the most common type of lupus and effects the whole body, according to the Cleveland Clinic. Symptoms of lupus typically develop slowly, and can include joint, muscle, or chest pain, headaches, rashes, fever, hair loss, mouth sores, fatigue, swollen glands, and swelling in arms, legs, or face. Further, patients usually experience flare-up symptoms, which can be severe enough to affect daily routines.4
Currently, there is only treatment for the symptoms of lupus, with the goal being to minimize damage to organs and the effect on everyday life. Hydroxychloroquine can be prescribed as a disease-modifying antirheumatic drug that relieves symptoms and slows progression of symptoms. OTC nonsteroidal anti-inflammatory drugs can help reduce pain and inflammation, and health care professionals might prescribe corticosteroids, such as prednisone, to reduce inflammation. Lastly, immunosuppressants are used to dull the immune system and stop it from being as active, thus preventing tissue damage and inflammation.4
Although lupus is not preventable, symptoms and flare-ups could be reduced through avoiding sun exposure, staying active, and getting enough sleep. There is no certain cause of lupus, but certain factors, such as genetics, hormones, and environment, could trigger lupus and various symptoms.4
READ MORE: Autoimmune Disease Resource Center
Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our free Drug Topics newsletter.
