Inflarx N.V. Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum

Published: 2025-05-28 02:50:25 ET IFRX

Published on 05/28/2025 at 02:50

InflaRx N.V. announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for Vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. This recommendation was based on data analysis of the first 30 patients enrolled in the study, with no unexpected adverse events noted by the IDMC. InflaRx as the study sponsor remains blinded to the study results.

GOHIBIC (vilobelimab) remains available in the US where it has been granted Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). The Company will continue its support of the BARDA-funded Phase 2 clinical platform study. In the EU, GOHIBIC (vilOBelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving IMV with or without ECMO.

In the U.S., GOHIBIC (vil Obelimab) has been awarded an Emergency Use Authorization by the Food & Drug Administration (FDA)for the treatment of COVID- 19 in hospitalized adults when initiated within48 hours of receiving invasive mechanical ventilation ("IMV") or extracorporeal membrane airation (ECMO). The emergency use of GOHIBIC (vil Cobelimab) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. SS 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner. GOHIBIC (villeobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID -19.

There is limited information known about the safety and effectiveness of using GOHIBIC (vil cobelimab) to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC website <1. In the EU, GO HIBIC (vilobelIMab) has been granted marketing authorized under exceptional circumstances for the treatment the treatment of adult patients withS-CoV-2- induced acute respiratory distress syndrome (ARDS") who are receiving systemic corticostoids as part of standard of Care and receiving invasive mechanical ventilation (IM V) with or without extracorporeal membrane oxygenated membrane oxygenation (ECMO); Under the terms of GOHIBIC's (vilobelimab's) approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.

The COVID-19 related work described herein was partly funded by the German Federal Government through grant number 16LW01.