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InflaRx Provides Update on Phase 3 Data Analyses for Vilobelimab in Pyoderma Gangrenosum
While the Phase 3 trial of vilobelimab in ulcerative pyoderma gangrenosum (PG) was terminated earlier this year due to futility regarding its prespecified primary endpoint (as previously disclosed), subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effectInflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates would only be conducted in co
About this update from Inflarx N.v.
[{"type":"image","alt":"InflaRx N.V.","displaySize":"","headline":null,"caption":"InflaRx N.V.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":157,"url":"https://media.zenfs.com/en/globenewswire.com/105c0226a90fc647941f68c2de55213a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/lqiU0gFIS0tiIdhYPTjZSw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIyMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/105c0226a90fc647941f68c2de55213a","width":300,"height":157}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"While the Phase 3 trial of vilobelimab in ulcerative pyoderma gangrenosum (PG) was terminated earlier this year due to futility regarding its prespecified primary endpoint (as previously disclosed), subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect","length":343,"tagName":"p"}]},{"val":[{"type":"text","content":"InflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates would only be conducted in collaboration with a partner","length":183,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":526,"olType":false},{"type":"text","content":"JENA, Germany, Dec. 30, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today outlined multiple data analyses of the Phase 3 study for vilobelimab in pyoderma gangrenosum (PG), which was terminated earlier this year after an Independent Data Monitoring Committee (IDMC) 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.","length":616,"tagName":"p"},{"type":"text","content":"Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “Our Phase 3 study was the first randomized placebo-controlled study in pyoderma gangrenosum using complete target ulcer closure on two consecutive visits as a stringent primary clinical endpoint, which has not been tested before in this rare disease. Our in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, ...