InflaRx Completes Enrollment in Vilobelimab (IFX-1) European Phase II Study in ANCA-associated Vasculitis
JENA, Germany, Jan. 05, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the European phase II IXCHANGE study of vilobelimab (IFX-1), a first-in-class anti-C5a antibody, in ANCA-associated vasculitis (AAV) has completed enrollment.
“We are pleased to have met our enrollment goal in the vilobelimab European phase II trial in AAV,” said Dr. Korinna Pilz, Global Head of Clinical Research and Development of InflaRx. “ANCA-associated vasculitis is a rare but recurring and life-threatening disease for which new treatment options are urgently needed. Given the suggested important role of the C5a signaling pathway, especially for the life-threatening flare phases in this disease, we believe that vilobelimab could be a promising therapeutic option and look forward to seeing the results from this trial and the US safety trial later this year.”
The randomized, double-blind, placebo-controlled phase II study enrolled 57 patients with AAV throughout Europe. The main objective of the study is to evaluate the safety and efficacy of vilobelimab in AAV. The study is being conducted in two parts. Part 1 compares vilobelimab plus a reduced dose of glucocorticoids versus a standard dose of glucocorticoids, while part 2 compares vilobelimab alone versus a standard dose of glucocorticoids. All patients receive standard of care immunosuppressive therapy (rituximab or cyclophosphamide). Each part of the study has a sixteen-week treatment period with an eight-week observational period. The primary efficacy endpoint of the study is the proportion of patients achieving a clinical response defined as a 50% reduction in Birmingham Vasculitis Activity Score (BVAS) at week 16 compared to baseline, a well-established endpoint that has been used in previous AAV studies. Secondary endpoints include clinical remission, evaluation of the Vasculitis Damage Index, reduction of glucocorticoid toxicity, several relevant other parameters such as glomerular filtration rate and patient reported outcomes. Part 1 of the study enrolled 30 patients while part 2 enrolled an additional 27 patients. Final results are expected by the end of 2021.