Hansa Biopharma announces U.S. FDA acceptance of Investigational New Drug (IND) application for Phase 3 study of imlifidase in anti-GBM disease
· Pivotal Phase 3 study to commence in 2022 and is expected to enroll 50 patients across the U.S. and Europe · Scientific advice on protocol obtained from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) with the aim of conducting a global study · Clinical Phase 2 data suggests that deactivation of autoantibodies by imlifidase could alter the course of this serious autoimmune disease Lund, Sweden, April 19, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), pioneer in enzyme technology for rare immunological conditions, today announces