InflaRx N.V. disclosed the results of post‑hoc analyses from its terminated Phase 3 trial of vilobelimab in pyoderma gangrenosum (PG). The study, which enrolled 54 patients before an independent data monitoring committee recommended early termination for futility on July 11 2025, now provides a detailed data release that includes the primary intent‑to‑treat endpoint and several secondary measures.
The primary endpoint—complete target ulcer closure on two consecutive visits—was 20.8% for vilobelimab versus 16.7% for placebo, a difference that was not statistically significant (p = NS). The lack of a significant benefit on the primary measure led to the trial’s early stop, underscoring the difficulty of demonstrating efficacy in this rare, heterogeneous disease.
Post‑hoc mixed‑model repeated‑measures analyses revealed a statistically significant 45.4% reduction in ulcer volume for vilobelimab compared with placebo (p = 0.0428). Other secondary signals included a 20.8% versus 5.6% rate of complete disease remission and a 36.4% versus 16.7% rate of >50% ulcer volume reduction at week 26, though these comparisons were also not statistically significant.
Safety data showed that vilobelimab was well tolerated. Treatment‑emergent adverse events were mild to moderate, and the incidence of serious events was comparable between the vilobelimab and placebo groups, supporting the drug’s safety profile in this patient population.
InflaRx plans to present the data to the FDA and is actively seeking partnership opportunities to advance vilobelimab in PG. The company is also prioritizing its oral C5aR inhibitor INF904 (Izicopan), which has shown promising Phase 2a results in hidradenitis suppurativa and chronic spontaneous urticaria. InflaRx’s cash position remains sufficient to fund operations through 2027, but the termination of the Phase 3 trial highlights the need for strategic collaborations to accelerate development.
CEO Prof. Niels C. Riedemann noted that the post‑hoc analyses “provide encouraging signals of efficacy, particularly in ulcer volume reduction, and reinforce the therapeutic potential of targeting the C5a/C5aR pathway in PG.” He added that the company remains committed to pursuing a partnership that can bring vilobelimab to patients while maintaining focus on its broader pipeline.
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