InflaRx reviews AAV strategy after EMA moves to revoke Tavneos

InflaRx N.V. (Nasdaq: IFRX) said it is assessing the feasibility of broadening its development strategy for ANCA-associated vasculitis (AAV) in Europe after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended revoking the marketing authorization for Tavneos in the European Union on June 26, 2026.

The company said it plans to engage with the EMA regarding two of its compounds: vilobelimab, an anti-C5a antibody approved in Europe under exceptional circumstances as Gohibic for SARS-CoV-2-induced acute respiratory distress syndrome, and izicopan, an oral C5a receptor inhibitor currently in Phase 2 planning for AAV. InflaRx said the Phase 2 planning for izicopan in AAV continues across multiple geographies without interruption.

InflaRx described vilobelimab as Phase 3-ready in AAV, citing completion of two Phase 2 studies — the European IXCHANGE trial and the U.S. IXPLORE trial. In IXCHANGE, vilobelimab was tested as a replacement for glucocorticoids on a background of standard-of-care rituximab or cyclophosphamide, with clinical response and remission rates described as comparable to standard-dose glucocorticoids and lower glucocorticoid-related toxicity. In IXPLORE, vilobelimab added to standard of care was described as well tolerated.

InflaRx's collaborator, Staidson BioPharmaceuticals Co., Ltd., is conducting a Phase 3 trial in China with BDB-001, an anti-C5a antibody produced using the vilobelimab cell line, following a Phase 1/2 study that showed comparable partial response rates and numerically higher complete response rates versus standard of care.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said the company is "committed to identifying the most efficient development pathway, with an overall goal for InflaRx of maximizing the value of these programs."

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