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InflaRx Announces Positive Data from Phase II IXCHANGE Study with Vilobelimab in ANCA-associated Vasculitis (AAV)
Proof of concept established for potential of vilobelimab to reduce use of corticosteroids in AAV patients: vilobelimab demonstrated comparable efficacy to
About this update from Inflarx N.v.
[{"type":"text","content":"Proof of concept established for potential of vilobelimab to reduce use of corticosteroids in AAV patients: vilobelimab demonstrated comparable efficacy to standard of careUse of vilobelimab instead of glucocorticoids led to a substantially lower observed glucocorticoid toxicityVilobelimab demonstrated a good safety and tolerability profile; vilobelimab only treatment arm had lowest number of reported treatment emergent adverse events JENA, Germany, Nov. 15, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced positive data from the European Phase II IXCHANGE study of vilobelimab, a first-in-class anti-C5a antibody, in patients with ANCA-associated vasculitis (AAV). The study achieved its principal objective, demonstrating comparable clinical response of vilobelimab to standard of care, while significantly reducing the need for glucocorticoid (GC) treatment in this life-threatening indication. “We are pleased to report that vilobelimab monotherapy has shown similar efficacy compared to a standard dose of glucocorticoids in patients with ANCA-associated vasculitis in this trial,” said Dr. Korinna Pilz, Chief Development Officer. “Vilobelimab treatment led to a considerably reduced use of glucocorticoids, resulting in remarkably less treatment emergent adverse events and a reduction in the glucocorticoid toxicity index.” “The results of the IXCHANGE trial regarding the evidence that vilobelimab has the potential to induce remission of ANCA-associated vasculitis with significant reduction in the dose and associated toxicity of glucocorticoids are exciting,” said Peter A. Merkel, MD, MPH, Professor of Medicine and Epidemiology at the University of Pennsylvania, Director of the Penn Vasculitis Center, and coordinating investigator for the study. “The strong efficacy and safety data in the trial are quite encouraging for the development of this novel agent for the treatment against this organ- and life-threatening disease.” The randomized, double-blind, placebo-controlled, two-part, Phase II IXCHANGE study enrolled 57 patients (30 in part 1; 27 in part 2) with AAV throughout Europe. Part 1 of the study compared vilobelimab plus a reduced dose of GC (RDGC) therapy to a standard dose of GC (SDGC) ther...