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Highlights

  • Independent committee recommends stopping Phase 3 trial in PG after interim futility review
  • InflaRx to redirect resources toward oral C5aR inhibitor INF904 with data expected summer 2025
  • Company considering additional cost-cutting to extend cash runway amid pipeline reprioritization

InflaRx N.V. (Nasdaq: IFRX) announced that its Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG) will be discontinued following a recommendation from the Independent Data Monitoring Committee (IDMC). The IDMC concluded that continuing the trial would be futile based on an unblinded interim analysis of data from the first 30 patients enrolled. The review did not raise any safety concerns or reveal unexpected adverse events.

The company stated it will cease development of vilobelimab for PG and shift its focus to INF904, an oral C5aR inhibitor. INF904 is currently being evaluated in Phase 2a trials for chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), with data readouts anticipated in summer 2025.

InflaRx is also evaluating potential cost-saving initiatives and resource reallocations to prolong its cash reserves. Although no specific financial figures were disclosed in the announcement, these strategic decisions reflect an effort to preserve capital and focus on assets with near-term clinical milestones.

Vilobelimab, branded as GOHIBIC, remains available in the U.S. under Emergency Use Authorization (EUA) for treating critically ill COVID-19 patients requiring invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). In Europe, the drug has marketing authorization under exceptional circumstances for similar use in SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) cases.

Despite the PG trial setback, InflaRx continues its involvement in the BARDA-funded Phase 2 COVID-19 platform study with vilobelimab. However, with this latest clinical development, investor attention may shift toward INF904 and the company's strategy to optimize its R&D pipeline within constrained financial parameters.