InflaRX N.V. (NASDAQ: IFRX) has announced positive findings from the Phase II IXCHANGE trial of its first in class anti-C5a antibody, vilobelimab, in treating ANCA-associated vasculitis patients.
Phase II IXCHANGE met the primary endpoint
The trial met its primary goal, demonstrating that vilobelimab has a clinical response that is comparable to the standard of care while dramatically lowering the requirement for glucocorticoid (GC) medication in this life-threatening condition.
Chief Development Officer Dr. Korina Pilz said, “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. 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.”
Professor of Medicine and Epidemiology at the University of Pennsylvania, Penn Vasculitis Center Director and study coordinator Peter Merkel said, “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. 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 study evaluated if vilobelimab can be used in place of GC therapy
The Phase II IXCHANGE study involved 57 patients with AAV from around Europe in a double-blind, randomized, placebo-controlled, two-part study. The trial’s first phase compared vilobelimab plus a reduced dose of GC therapy (RDGC) to a normal dose of GC therapy (SDGC), whereas the second section compared vilobelimab to SDGC. Immunosuppressive therapy was given to all of the patients as part of their standard of care. Patients received 800 mg of vilobelimab after every two weeks for 16 weeks after receiving loading doses on days 1, 4, and 8, followed by an eight-week observation period. The study’s primary goal was to see if vilobelimab might be used instead of GC therapy in patients with Microscopic Polyangiitis (MPA) and Granulomatosis with Polyangiitis (GPA).