InflaRx N.V. (NASDAQ: IFRX) is reigniting interest in its investigational drug vilobelimab following fresh insights derived from additional analyses of a Phase 3 clinical trial in pyoderma gangrenosum (PG). This trial was originally terminated early in 2025 after an Independent Data Monitoring Committee (IDMC) identified futility, prompting a halt to the study. New post-hoc analyses, however, have generated signals indicative of a consistent beneficial treatment effect, encouraging the biopharmaceutical company to engage with the U.S. Food and Drug Administration (FDA) and explore potential collaborations to advance the compound’s clinical development.
Trial Background and Disease Overview
The Phase 3 trial assessed vilobelimab’s efficacy in pyoderma gangrenosum, a rare and painful dermatologic disorder marked by rapidly developing red papules or nodules that evolve into sizable, deep ulcers. These ulcers typically present with a distinctive purple, undermined border and, despite the name, are not caused by infection or gangrene. The disease severely impairs patient quality of life due to pain and chronic wounds.
Details of Recent Analyses
InflaRx recently disclosed multiple analyses concerning the 54 patients enrolled when the trial was halted. The primary intent-to-treat (ITT) analysis reported the clinical endpoint of complete ulcer closure on two consecutive visits was achieved by 20.8% of vilobelimab-treated patients compared with 16.7% in the placebo arm; this difference did not reach statistical significance (p=NS). Secondary endpoints also favored vilobelimab, though without statistical significance, including:
- Complete disease remission, defined as total closure of all ulcers (20.8% vs 5.6%, p=NS)
- More than 50% reduction in target ulcer volume at week 26 (36.4% vs 16.7%, p=NS)
Patient-reported outcomes measured through the Dermatology Life Quality Index (DLQI) further indicated improvement, with mean percentage change at treatment end showing a 31.1% reduction in symptom burden for the vilobelimab group, compared to a 3.4% increase for placebo recipients.
Post-Hoc Analytical Insights
In addition to the primary and secondary endpoint results, the company conducted further post-hoc evaluations including a mixed model repeated measures (MMRM) analysis of percentage changes in ulcer volume over 26 weeks. This analysis demonstrated a statistically significant treatment effect for vilobelimab compared to placebo, with an average reduction of 45.4% (p=0.0428). Noteworthy, treatment differences were significant from Week 14 through Week 26, with reductions in ulcer volume exceeding 50% and reaching 63.2% by the final analyzed time point.
The analyses also suggest potential benefits from extended treatment durations beyond 26 weeks, although this requires further validation.
Next Steps and Strategic Focus
InflaRx intends to initiate discussions with the FDA concerning possible regulatory pathways for vilobelimab in PG. These talks may address acceptance of alternative clinical endpoints for future studies, which could facilitate drug approval. However, the company has indicated that it will not heavily invest its own resources in advancing vilobelimab independently in this indication. Instead, InflaRx is prioritizing the development of izicopan (INF904), an orally administered complement inhibitor currently being evaluated in inflammatory conditions such as hidradenitis suppurativa and chronic spontaneous urticaria.
InflaRx is considering seeking external partners to support continuing vilobelimab development programs, leveraging collaboration to share costs and expertise while preserving focus on its prioritized pipeline assets.
Market Reaction
Shares of InflaRx closed at $1.09 on Friday, marking a 7.92% increase according to Benzinga Pro data, reflecting investor interest in the newly presented data and potential development outlook.
Regarding safety, vilobelimab was generally well tolerated in the study population, consistent with prior assessments.
Summary
InflaRx’s reanalysis of data from a prematurely discontinued Phase 3 clinical trial for vilobelimab in pyoderma gangrenosum has unveiled encouraging signals of efficacy. This development prompts prospective FDA engagement and suggests that future clinical efforts may incorporate different efficacy measures. While the company concentrates resources on izicopan’s advancement, it remains open to partners assuming stewardship of vilobelimab’s clinical trajectory.