InflaRx N.V. (NASDAQ:IFRX) provided an update on its Phase 3 study of vilobelimab in pyoderma gangrenosum (PG), outlining multiple data analyses after the trial was terminated earlier this year due to futility, following a recommendation from an Independent Data Monitoring Committee (IDMC).
The company disclosed findings from the primary intent-to-treat analysis and several post-hoc analyses, based on data from the 54 patients enrolled at the time of study termination.
The study aimed to evaluate vilobelimab, a C5a/C5aR pathway inhibitor, as a treatment for PG, a rare and debilitating neutrophilic skin disease.
The primary endpoint of complete target ulcer closure on two consecutive visits showed a difference in favor of vilobelimab over placebo, with a 20.8% closure rate in the vilobelimab arm versus 16.7% in the placebo group (p=NS).
Key secondary endpoints, such as complete disease remission and >50% reduction in target ulcer volume, also showed improvements in favor of vilobelimab, though these were not statistically significant.
Patients treated with vilobelimab also reported better quality of life, as measured by the Dermatology Life Quality Index (DLQI), with a mean percentage change of -31.1% compared to 3.4% in the placebo arm.