InflaRx Outlines Data Analysis for Vilobelimab in Pyoderma Gangrenosum Study

InflaRx outlined multiple data analyses of the Phase 3 study for vilobelimab in pyoderma gangrenosum, which was terminated earlier this year after an Independent Data Monitoring Committee recommended the trial be stopped early due to futility. The analyses disclosed today include the primary intent-to-treat analysis and several post-hoc analyses on the 54 patients enrolled in the trial at the time of study termination. The Phase 3 study had recruited a total of 54 patients at the time the interim analysis was conducted, including 30 patients who had completed 6 months of treatment. The primary clinical endpoint of complete target ulcer closure on two consecutive visits showed a difference in favor of vilobelimab over placebo of 20.8% versus 16.7%. Key secondary endpoints such as complete disease remission showed improvement in favor of vilobelimab over placebo and those with greater than50% reduction of target ulcer volume at week 26. In addition, patients reported feeling better as measured by the Dermatology Life Quality Index mean percentage change at the end of treatment visit. Overall, vilobelimab was well tolerated. Observed treatment-emergent adverse events were mostly mild to moderate, and patients with serious related on-treatment TEAEs were similarly distributed. In addition, further post-hoc analyses showed that there is an overall treatment effect with vilobelimab when compared to placebo. These include an MMRM for percent change in target ulcer volume, which showed an average effect over all visits in favor of vilobelimab over placebo when imputing patients with treatment-related discontinuation reasons, including patient level stopping criteria with a last observation carried forward approach. This analysis yielded a significant treatment difference for every week from Week 14 to Week 26 for vilobelimab over placebo. In addition, ANCOVAs for mean of percentage changes from baseline in volume and area from Week 12 until Week 26 were also in favor of vilobelimab, including mean of percentage change from baseline in volume and area. These analyses suggest that treatment longer than 26 weeks with vilobelimab may provide improved treatment outcomes in this difficult-to-treat ulcerative PG population. As next steps, InflaRx anticipates meeting with the FDA to discuss a potential path forward for vilobelimab in PG, including the use of alternative endpoints that could be utilized for potential future clinical studies. At this time, in an effort to prioritize izicopan development, InflaRx does not expect to deploy significant resources towards future vilobelimab development in PG on its own and will instead consider doing so in collaboration with a partner.