InflaRx N.V. (NASDAQ:IFRX) is reviving hopes for vilobelimab after new analyses showed signs of efficacy in a Phase 3 trial it had previously halted, setting up FDA talks and a potential partner-led path forward.
Last Tuesday, the company outlined multiple data analyses of the Phase 3 study for vilobelimab in pyoderma gangrenosum (PG), which was terminated earlier in 2025 after an Independent Data Monitoring Committee (IDMC) recommended the trial be stopped early due to futility.
Subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect, the company said.
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Pyoderma gangrenosum (PG) is a rare, painful skin condition characterized by red bumps that quickly develop into large, deep, open ulcers, often with a purple, undermined border, although it’s not caused by infection or gangrene.
FDA Discussions and Potential Partner Strategy
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.
In an effort to prioritize izicopan (INF904) 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.
In November 2025, InflaRx revealed topline data from a Phase 2a basket study exploring INF904 in hidradenitis suppurative and chronic spontaneous urticaria.
The analyses disclosed on Tuesday 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.
Primary and Secondary Endpoint Results
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% (p=NS (not significant)).
Key secondary endpoints, such as complete disease remission (complete closure of all ulcers), showed improvement in favor of vilobelimab over placebo (20.8% versus 5.6%, p=NS) and those with >50% reduction of target ulcer volume at week 26 (36.4% versus 16.7%, p=NS).
In addition, patients reported feeling better as measured by the Dermatology Life Quality Index (DLQI) mean percentage change at the end of the treatment visit (-31.1% versus 3.4%).
Overall, vilobelimab was well tolerated.
Post-Hoc Analyses Show Consistent Treatment Effect
In addition, further post-hoc analyses showed that there is an overall treatment effect with vilobelimab when compared to placebo.
These include an MMRM (mixed model repeated measures) for percent change in target ulcer volume, which showed an average effect over all visits in favor of vilobelimab over placebo (-45.4%, p=0.0428, Weeks 2 – 26 overall) when imputing patients with treatment-related discontinuation reasons.
The analysis yielded a significant treatment difference for every week from Week 14 (-57.6%, p=0.0357) to Week 26 (-63.2%, p=0.0122) for vilobelimab over placebo.
The analyses also suggest that treatment longer than 26 weeks with vilobelimab may provide improved treatment outcomes.
IFRX Price Action: IFRX stock closed at $1.09, up 7.92% on Friday, according to Benzinga Pro data.
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