Cabaletta Bio Announces New Rese-cel Safety and Efficacy Data in Patients with Myositis, Lupus and Scleroderma to Be Presented at the EULAR 2025 Congress

Core Insights - Cabaletta Bio, Inc. announced promising clinical data from its ongoing RESET clinical trials for autoimmune diseases, highlighting the potential of rese-cel to provide drug-free, symptom-free lives for patients [1][2][6] Clinical Trial Results - In the RESET-Myositis trial, 7 out of 8 patients achieved clinically meaningful total improvement scores (TIS) while off all immunomodulators and steroids, with 4 patients experiencing grade 1 cytokine release syndrome (CRS) [1][2][3] - All systemic lupus erythematosus (SLE) patients without nephropathy achieved remission as per DORIS criteria, with 7 out of 7 patients responding clinically while off immunomodulators and glucocorticoids [1][2] - Both patients in the RESET-SSc trial showed significant improvements in modified Rodnan Skin Score (mRSS) after discontinuing immunomodulatory drugs, with one patient meeting the revised Composite Response Index in Systemic Sclerosis (CRISS) criteria [1][8] Safety Profile - Among 18 patients with follow-up of 4 weeks or more, 94% experienced no CRS or only Grade 1 CRS, and 89% had no immune effector cell-associated neurotoxicity syndrome (ICANS) [1][2] - In the RESET-SLE trial, 2 out of 8 patients experienced grade 1 CRS, and one ICANS event was reported [3][8] Regulatory and Development Plans - Cabaletta plans to initiate enrollment in two registrational myositis cohorts in 2025 and has scheduled discussions with the FDA regarding registrational pathways for SLE/LN in 3Q25, scleroderma in 4Q25, and myasthenia gravis in 1H26 [1][9] - The RESET clinical trial program is accelerating, with 51 patients actively enrolled across over 65 clinical sites as of May 30, 2025 [1][2][6] Company Overview - Cabaletta Bio is focused on developing curative targeted cell therapies for autoimmune diseases, with rese-cel being a key investigational therapy designed to deplete CD19-positive B cells [5][6] - The company aims to change treatment paradigms for autoimmune diseases through its innovative CARTA platform, which includes multiple disease-specific clinical trials [5][6]