InflaRx Halts Rare Skin Disease Study for Vilobelimab After Futility Signal

InflaRx stopped its Phase 3 trial of vilobelimab for pyoderma gangrenosum (PG) following a futility recommendation from the Independent Data Monitoring Committee (IDMC) after interim analysis of the first 30 patients enrolled12.

The IDMC's recommendation was based on efficacy (futility), but no unexpected adverse events were reported in the interim review12.

InflaRx will discontinue further development of vilobelimab in PG and shift resources to its oral C5aR inhibitor, INF904, which is being tested in other immune-dermatological conditions with data expected in summer 202512.

Vilobelimab (marketed as GOHIBIC) continues to be investigated for other indications, including as a potential treatment for COVID-19-related ARDS under an Emergency Use Authorization in the U.S.35.

Sources:

1. https://www.inflarx.de/Home/Investors/Press-Releases/Press-Release~2025-05-InflaRx-Announces-Outcome-of-Interim-Analysis-for-Vilobelimab-Phase-3-Trial-in-Pyoderma-Gangrenosum~.html

2. https://www.globenewswire.com/news-release/2025/05/28/3089141/0/en/InflaRx-Announces-Outcome-of-Interim-Analysis-for-Vilobelimab-Phase-3-Trial-in-Pyoderma-Gangrenosum.html

3. https://www.inflarx.de/Home/Investors/Press-Releases/05-2025-InflaRx-Reports-First-Quarter-2025-Financial-Results-and-Provides-Business-Update.html

5. https://www.globenewswire.com/news-release/2025/05/07/3075994/0/en/InflaRx-Reports-First-Quarter-2025-Financial-Results-and-Provides-Business-Update.html