InflaRX Presents Efficacy and Safety Data on Vilobelimab at AAD 2025

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Biopharmaceutical company InflaRx N.V. presented 6 scientific posters on the clinical development of vilobelimab at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.¹ The new data on clinical efficacy and safety as well as pharmacokinetic and pharmacodynamic analysis supports vilobelimab’s role in the treatment of pyoderma gangrenosum and hidradenitis suppurativa.

“At AAD 2025, we presented multiple data sets we believe collectively paint a broad and positive picture of vilobelimab’s potential in addressing inflammatory conditions such as hidradenitis suppurativa and pyoderma gangrenosum. Multiple safety analyses showed vilobelimab to be well-tolerated in HS, and in the rare and devastating disease of PG, in which patients are often very ill and have co-morbidities,” Chief Medical Officer, Camilla Chong, MD, said in a statement.¹

“We also presented data showing vilobelimab can reduce and resolve draining tunnels, including a 3.1x relative improvement in dT100 response. Multiple analyses also showed vilobelimab can promote significant and sustained reductions in C5a, which is a key mediator of the inflammatory cascade. We believe that the C5a/C5aR pathway remains critical in these neutrophilic-driven diseases,” Chong added.¹

Vilobelimab and Pyoderma Gangrenosum

Phase 2a trials confirmed the safety and tolerability of vilobelimab for patients with pyoderma gangrenosum. Across all doses, the therapy was well tolerated with no safety concerns or relevant findings based on vital signs, ECGs, hematology, clinical chemistries, or urinalysis. Any adverse events were mild to moderate.

Further pharmacokinetic and pharmacodynamic analysis showed that C5a decreased throughout the entire study. An approximate 90% reduction from baseline was observed by day 15 in all dose groups. More specifically, the cohorts utilizing 1600 mg bi-weekly and 2400 mg bi-weekly administrations saw the improvement up to day 99. It was also suggested that dosages greater than 1600mg are best to suppress C5a in patients with ulcerative pyoderma gangrenosum.

Vilobelimab and Hidradenitis Suppurativa

Data from the phase 2bSHINE trial supported the efficacy and safety of vilobelimab in hidradenitis suppurativa. According to a post-hoc analysis, vilobelimab had a greater reduction in the mean count of draining tunnels when compared to placebo (-63.2% versus -18.0%). Additionally, a significantly higher rate of complete resolution (dT100) was observed in vilobelimab versus placebo(40.9% and 13.0%, respectively). This equates to a 3.1x relative responder improvement in favor of vilobelimab. Regarding its safety, similar adverse effects were reported at all doses compared to placebo, in both the main trial and the extension period.

The pharmacokinetic and pharmacodynamic analysis showed that 800mg of vilobelimab resulted in trough levels, significantly reducing C5a concentrations from Day 1. A residual treatment effect was noted with C5a concentrations gradually increasing after treatment but still remaining lower than baseline levels up to the follow-up at day 134.

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody without altering the membrane attack complex (C5b-9). Pre-clinical data demonstrated its ability to control the inflammatory response-driven tissue and organ damage. Vilobelimab has been granted orphan drug designation by the FDA and the EMA, as well as fast-track designation by the FDA for the treatment of pyoderma gangrenosum. Phase 3 trials for pyoderma gangrenosum are underway, with a 2400 mg bi-weekly dosage.

Reference

1. InflaRx Showcases Vilobelimab’s Role in Immuno-Dermatology at the 2025 AAD Annual Meeting. News Release. Globe Newswire. Published March 7, 2025. Accessed March 11, 2025. https://www.globenewswire.com/news-release/2025/03/07/3038913/0/en/InflaRx-Showcases-Vilobelimab-s-Role-in-Immuno-Dermatology-at-the-2025-AAD-Annual-Meeting.html