InflaRx Revives Hope for Vilobelimab in Pyoderma Gangrenosum, Seeks Partner for Development

German pharmaceutical company InflaRx has announced renewed interest in its C5a antibody vilobelimab for the treatment of pyoderma gangrenosum (PG), a rare skin disorder. This development comes after the company's initial decision to terminate a phase 3 trial in May 2025 due to futility. Post hoc analyses of the terminated study have revealed promising trends, prompting InflaRx to consider reviving the drug's development in collaboration with a partner.

Positive Signals from Post Hoc Analyses

Despite the early termination of the phase 3 trial, InflaRx's subsequent analyses have uncovered encouraging data. The primary clinical endpoint of complete target ulcer closure on two consecutive visits showed a difference favoring vilobelimab (20.8%) over placebo (16.7%), although this difference did not meet the trial's predefined significance threshold.

Additional secondary endpoints demonstrated further positive trends:

• Nearly 30% of patients on vilobelimab achieved complete disease remission, compared to 5.6% in the placebo group.
• 36.4% of vilobelimab-treated patients experienced a 50% or greater reduction in ulcer volume at 26 weeks, versus 16.7% of placebo patients.

Dr. Niels Riedemann, InflaRx's CEO, stated, "Our in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, which further supports the potential role of the C5a/C5aR pathway in certain neutrophilic skin diseases, such as PG."

Potential Development Path and Partnership

InflaRx anticipates meeting with the FDA to discuss a potential development path forward for vilobelimab in PG. The company is considering alternative endpoints and extended treatment durations based on the post hoc analyses, which suggested that dosing beyond 26 weeks may provide improved outcomes.

However, InflaRx has made it clear that any future development of vilobelimab in PG would only be pursued in collaboration with a partner. This decision aligns with the company's current focus on prioritizing resources for its oral small molecule candidate, izicopan, in conditions such as chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS).

Vilobelimab's Current Status and Future Prospects

While vilobelimab's development in PG faced setbacks, the drug maintains an emergency use authorization (EUA) for treating certain critically ill COVID-19 patients under the brand name Gohibic. This authorization remains unaffected by the PG trial termination.

Dr. Benjamin Kaffenberger of The Ohio State University Wexner Medical Center expressed optimism about vilobelimab's potential in PG, stating, "I believe that blocking C5a/C5aR in this neutrophilic disease continues to make scientific and clinical sense and that there is a strong justification to move forward."

As InflaRx navigates the future of vilobelimab in PG, the company continues to advance its broader pipeline, particularly focusing on izicopan, which has shown promise in recent phase 2a studies for both HS and CSU. With a reported cash runway extending into 2027, InflaRx appears well-positioned to pursue its development goals while seeking potential partnerships for vilobelimab's future in PG.