InflaRx commences second Phase 2 trial of IFX-1
InflaRx announced the treatment of the first patient in IXchange, a Phase 2 study with IFX-1 in patients with ANCA-associated vasculitis, or AAV. AAV is a rare and life-threatening autoimmune disease in which activation of the complement system, and specifically generation of C5a, is believed to play a key role in the neutrophil-driven vessel inflammation that defines the disease. The disease affects approximately 40,000 and 75,000 patients in the United States and Europe, respectively. The main objective of this randomized, double-blind, placebo-controlled Phase II study is to evaluate the efficacy and safety of IFX-1 in patients with moderate to severe AAV. The trial is planned to enroll approximately 80 patients at about 60 sites in up to 12 European countries and Russia. The study will be conducted in two parts. In Part 1, patients are being randomized to receive either IFX-1 plus a reduced dose of glucocorticoids, or placebo plus a standard dose of glucocorticoids. Patients in both arms will receive the standard of care dosing of immunosuppressive therapy. Prior to starting Part 2 of the study, an independent data monitoring committee will evaluate the efficacy and safety results from Part 1 and recommend if the study should continue. Part 2 will evaluate if treatment with IFX-1 alone is as effective as IFX-1 in combination with glucocorticoids. Thus, in Part 2 patients will be randomized to receive IFX-1 plus placebo glucocorticoids versus placebo plus a standard dose of glucocorticoids. Patients in both arms will receive standard of care immunosuppressive therapy. The primary endpoint of the study is a 50% reduction in Birmingham Vasculitis Activity Score, or BVAS, at week 16, an endpoint that has been used in the previous AAV studies. Secondary efficacy endpoints being analyzed include clinical remission, evaluation of the Vasculitis Damage Index, reduction of glucocorticoid toxicity, several relevant biomarkers like glomerular filtration rate and patient reported outcomes.