Healthcare
InflaRx Assessing Feasibility of Broadened Strategy for ANCA‑Associated Vasculitis in Europe Following EMA Recommendation on Tavneos
InflaRx intends to engage with EMA regarding both vilobelimab and izicopan to evaluate the regulatory path to approval in ANCA-associated vasculitis (AAV)The Company is assessing the most efficient development plan to bring the C5a/C5aR inhibition mechanism to patientsPreviously announced Phase 2 planning with izicopan in AAV continues uninterrupted Jena, Germany, June 30, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics
About this update from Inflarx N.v.
Jena, Germany, June 30, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced it is assessing the feasibility of broadening its development and registrational strategy for AAV in Europe. The company has initiated this assessment given the recommendation of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to revoke the marketing authorization for Tavneos in the European Union, announced on June 26, 2026. The Company announced it intends to engage with EMA regarding both its anti-C5a antibody vilobelimab, which is approved under exceptional circumstances as GOHIBIC in Europe for SARS-CoV-2-induced acute respiratory distress syndrome, in addition to its next-generation oral C5aR inhibitor izicopan. This will be part of the Company's overall development goal to determine the most efficient development pathway to bring the C5a/C5aR inhibition mechanism to patients. The previously announced Phase 2 planning with izicopan in AAV continues as planned and uninterrupted across multiple geographies. InflaRx considers vilobelimab to be a Phase 3-ready asset in AAV, where it has completed two Phase 2 studies in the U.S. and Europe. In addition, BDB-001, a vilobelimab cell line-produced antibody, has completed Phase 2 development and is being evaluated by InflaRx's collaborator, Staidson BioPharmaceuticals Co., Ltd. (Staidson), in a Phase 3 trial in AAV in China. Together, vilobelimab and izicopan provide InflaRx with a complementary biologic and oral pipeline that is well positioned to address the evolving treatment landscape and significant unmet medical need in AAV. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: "Recent developments in the ANCA-associated vasculitis treatment landscape reinforce both the seriousness of this disease and the importance of therapies with a strong mechanistic rationale, robust clinical evidence and a differentiated benefit-risk profile. InflaRx has deep scientific and clinical experience with the C5a/C5aR pathway, and with our anti-C5a antibody vilobelimab and our next-generation oral C5aR inhibitor izicopan, we have built a differentiated portfolio targeting this mechanism. We are committed to identifying the most efficient development...