Hansa Biopharma to initiate Phase 3 study of imlifidase to treat anti-Glomerular Basement Membrane (anti-GBM) disease after successful pre-IND meeting with U.S. FDA
· Pivotal Phase 3 study to commence in 2022 and is expected to enroll approximately 50 patients across the U.S. and Europe · Advice procedure also initiated with the European Medicines Agency · Marks important milestone in the expansion of imlifidase into autoimmune diseases Lund, Sweden November 15, 2021. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today announces its decision to initiate a pivotal Phase 3 clinical study of imlifidase to treat anti-GBM disease, following a successful pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (