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.
Post-hoc analyses indicated a significant treatment effect with vilobelimab, particularly in terms of target ulcer volume reduction.
A mixed model repeated measures (MMRM) analysis revealed an average -45.4% change in ulcer volume favoring vilobelimab over placebo (p=0.0428) from Weeks 2 to 26, with significant differences at Week 14 (-57.6%, p=0.0357) and Week 26 (-63.2%, p=0.0122).
Further analyses also showed significant improvements in volume and area changes from baseline to Week 26 in favor of vilobelimab (p=0.0111 for volume, p=0.0072 for area).
The company emphasized that vilobelimab was generally well tolerated, with treatment-emergent adverse events (TEAEs) mostly mild to moderate, and serious related TEAEs observed at similar rates between the vilobelimab and placebo arms.
InflaRx plans to meet with the U.S. Food and Drug Administration to discuss a potential path forward for vilobelimab in PG, including the possibility of using alternative endpoints for future clinical studies.
However, the company is prioritizing the development of izicopan (INF904) and does not expect to devote significant resources to further vilobelimab development in PG independently.
Instead, InflaRx is considering collaboration with a partner to advance the program.
The company remains committed to advancing its pipeline and exploring new treatment options for patients with rare diseases like PG.