InflaRx Reviews Phase 3 Data for Vilobelimab in Pyoderma Gangrenosum After Early Trial Termination

Reuters2025-12-30

InflaRx Reviews Phase 3 Data for Vilobelimab in Pyoderma Gangrenosum After Early Trial Termination

InflaRx N.V. has provided an update on the Phase 3 clinical study of vilobelimab for the treatment of pyoderma gangrenosum $(PG)$. The trial was terminated earlier in the year after an Independent Data Monitoring Committee recommended stopping the study due to futility with respect to its prespecified primary endpoint. Subsequent post-hoc analyses of the 54 enrolled patients indicate a positive trend in favor of vilobelimab, particularly in terms of ulcer volume reduction. InflaRx has disclosed these data analyses and anticipates meeting with the FDA to discuss potential future development paths for vilobelimab in PG, including the possibility of using alternative clinical endpoints. The company has stated that any further development in this indication would likely occur in collaboration with a partner.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Inflarx NV published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9618161-en) on December 30, 2025, and is solely responsible for the information contained therein.

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The trial was terminated earlier in the year after an Independent Data Monitoring Committee recommended stopping the study due to futility with respect to its prespecified primary endpoint. Subsequent post-hoc analyses of the 54 enrolled patients indicate a positive trend in favor of vilobelimab, particularly in terms of ulcer volume reduction. InflaRx has disclosed these data analyses and anticipates meeting with the FDA to discuss potential future development paths for vilobelimab in PG, including the possibility of using alternative clinical endpoints. The company has stated that any further development in this indication would likely occur in collaboration with a partner.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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The trial was terminated earlier in the year after an Independent Data Monitoring Committee recommended stopping the study due to futility with respect to its prespecified primary endpoint. Subsequent post-hoc analyses of the 54 enrolled patients indicate a positive trend in favor of vilobelimab, particularly in terms of ulcer volume reduction. InflaRx has disclosed these data analyses and anticipates meeting with the FDA to discuss potential future development paths for vilobelimab in PG, including the possibility of using alternative clinical endpoints. The company has stated that any further development in this indication would likely occur in collaboration with a partner.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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The trial was terminated earlier in the year after an Independent Data Monitoring Committee recommended stopping the study due to futility with respect to its prespecified primary endpoint. Subsequent post-hoc analyses of the 54 enrolled patients indicate a positive trend in favor of vilobelimab, particularly in terms of ulcer volume reduction. InflaRx has disclosed these data analyses and anticipates meeting with the FDA to discuss potential future development paths for vilobelimab in PG, including the possibility of using alternative clinical endpoints. The company has stated that any further development in this indication would likely occur in collaboration with a partner.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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