InflaRx N.V. (IFRX) today released detailed analyses from its terminated Phase 3 trial of Vilobelimab in pyoderma gangrenosum. The study was stopped in May 2025 after an Independent Data Monitoring Committee (IDMC) recommended discontinuation for futility, and subsequent post-hoc analyses of the full dataset have revealed signals of efficacy that the company believes warrant further consideration.
Pyoderma gangrenosum (PG) is a rare, ulcerative neutrophilic skin disease with no FDA- approved therapies. Patients often suffer from painful, non-healing ulcers, and treatment options remain limited.
InflaRx's Phase 3 study was the first randomized, placebo-controlled trial in PG to use complete target ulcer closure on two consecutive visits as its primary endpoint.
At the time of termination, 54 patients had been enrolled, with 30 completing six months of treatment. The primary endpoint showed a non-significant difference between Vilobelimab and placebo, but secondary measures suggested potential benefit. Complete disease remission was observed in 20.8 percent of patients receiving Vilobelimab compared to 5.6 percent on placebo, while 36.4 percent achieved more than a 50 percent reduction in target ulcer volume versus 16.7 percent in the placebo group.
Patients also reported improved quality of life, with Dermatology Life Quality Index scores decreasing by 31.1 percent compared to a slight increase in the placebo arm.
Safety data indicated that Vilobelimab was generally well tolerated, with adverse events mostly mild to moderate.
Post-hoc analyses provided further evidence of treatment effect. A mixed model repeated measures analysis showed significant reductions in ulcer volume from week 14 through week 26 in favor of Vilobelimab, while analyses of covariance also demonstrated statistically significant improvements in ulcer volume and area.
These findings suggest that longer treatment duration may yield improved outcomes in this difficult-to-treat patient population.External investigators expressed cautious optimism, noting that while the primary endpoint was not met, the data support the scientific rationale for targeting the C5a/C5aR pathway in pyoderma gangrenosum.
InflaRx emphasized that the trial's early termination was based on interim data from the first 30 patients, which did not reveal sufficient efficacy signals at that stage.
The company explained that the more comprehensive analyses conducted after study closure provided a clearer picture of Vilobelimab's potential.
InflaRx now plans to meet with the FDA to discuss possible alternative endpoints,and noted that future development in PG would likely be pursued in collaboration with a partner, given its current focus on advancing its oral C5aR inhibitor, Izicopan (INF904).
Vilobelimab, marketed as GOHIBIC, remains available in the United States under Emergency Use Authorization for the treatment of COVID-19 in hospitalized adults requiring invasive mechanical ventilation or extracorporeal membrane oxygenation, and has also received marketing authorization in the European Union under exceptional circumstances for acute respiratory distress syndrome caused by SARS-CoV-2.
For the six months ended June 30, 2025, InflaRx reported €39 thousand in revenues from U.S. sales of GOHIBIC compared to €42 thousand in the year-ago period.
IFRX has traded between $0.71 and $2.77 over the past year. The stock is currently trading in the pre-market at $0.97, down 4.89%.
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