InflaRx receives European approval to initiate IFX-1 study
InflaRx announced the approval of an investigational medicinal product dossier, or IMPD, from the European regulatory authorities, allowing InflaRx to initiate a phase II study with IFX-1, an anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis. The randomized, double-blind, placebo-controlled phase II study is planned to enroll approximately 80 patients with AAV at about 60 sites in Europe. The main objective of the study is to evaluate the efficacy and safety of IFX-1 in this patient population. The study will be conducted in two parts. Part 1 will compare IFX-1 plus a reduced dose of glucocorticoids versus a standard dose of glucocorticoids, while part 2 will compare IFX-1 alone versus a standard dose of glucocorticoids. All patients will receive standard of care immunosuppressive therapy. The study is expected to initiate in Q1 of 2019.