InflaRx N.V. announced on May 28, 2025, that the Independent Data Monitoring Committee (IDMC) recommended stopping the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG) due to futility. This recommendation was based on an unblinded interim analysis of data from the first 30 patients enrolled in the study.
The IDMC noted no unexpected adverse events during the trial. Following this outcome, InflaRx intends to discontinue further development of vilobelimab in the PG indication.
The company will now prioritize its resources on INF904, its oral C5aR inhibitor, with Phase 2a data readouts in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) anticipated this summer. InflaRx is also considering additional cost savings and resource redirection to extend its existing cash runway. GOHIBIC (vilobelimab) remains available in the US under Emergency Use Authorization and has European marketing authorization for SARS-CoV-2-induced ARDS.
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