Post-Hoc Data Analysis Shows Encouraging Signals For Vilobelimab Despite Phase 3 Trial Discontinuation

InflaRx N.V. (IFRX) has disclosed additional findings from its discontinued Phase 3 trial evaluating Vilobelimab for pyoderma gangrenosum, a rare ulcerative skin condition characterized by painful non-healing wounds. Although the study was halted in May 2025 on the recommendation of an Independent Data Monitoring Committee due to insufficient early signals, subsequent comprehensive analysis of the complete dataset has surfaced promising efficacy indicators.

The Trial and Disease Context

Pyoderma gangrenosum remains therapeutically challenging, with patients currently lacking FDA-approved treatment options. The trial represented the first randomized, placebo-controlled investigation in this indication to employ complete target ulcer closure on sequential visits as the primary efficacy measure. Out of 54 enrolled participants, 30 completed the full six-month treatment course.

Primary Endpoint Versus Secondary Findings

The prespecified primary endpoint failed to demonstrate statistical significance between the Vilobelimab-treated cohort and placebo recipients. However, secondary and exploratory measures painted a more nuanced picture. Disease remission was achieved by 20.8 percent of Vilobelimab patients versus 5.6 percent receiving placebo. When examining ulcer volume reductions exceeding 50 percent, 36.4 percent of the treated group met this threshold compared to 16.7 percent in controls. Quality of life metrics also favored treatment, with Dermatology Life Quality Index scores declining 31.1 percent in the active arm while rising slightly among placebo recipients.

Mechanistic Rationale and Extended Analysis

The delayed analytical work, including mixed model repeated measures and covariance analyses, demonstrated statistically significant ulcer volume improvements from weeks 14 through 26 favoring Vilobelimab. These results suggest that extended treatment duration may optimize clinical benefit in this difficult-to-manage patient population. The compound targets the C5a complement pathway, a mechanism independent investigators consider biologically sound for this indication.

Tolerability Profile

Vilobelimab demonstrated acceptable safety, with adverse events predominantly mild to moderate in severity.

Commercial Status and Next Steps

GOHIBIC, the marketed formulation of Vilobelimab, maintains emergency use authorization in the United States for hospitalized COVID-19 patients requiring mechanical ventilation or extracorporeal membrane oxygenation support. The European Union has granted conditional marketing approval for acute respiratory distress syndrome attributed to SARS-CoV-2. Six-month revenues from U.S. GOHIBIC sales totaled €39 thousand as of June 30, 2025, compared with €42 thousand year-over-year.

InflaRx intends regulatory engagement with the FDA regarding modified endpoint structures, while future pyoderma gangrenosum development will likely proceed through partnership arrangements. The company is prioritizing its oral C5aR inhibitor candidate, Izicopan (INF904). IFRX equity has fluctuated between $0.71 and $2.77 over the preceding twelve months, currently trading in early session quotation at $0.97, reflecting a 4.89 percent decline.