Post Hoc Analysis of Vilobelimab in Hidradenitis Suppurativa Suggests Clinically Meaningful Benefits

InflaRx recently presented new data from a post hoc analysis of the SHINE Phase 2b study on vilobelimab, an anti-C5a antibody, in patients with moderate to severe hidradenitis suppurativa (HS).¹

The data was showcased as an e-poster at the European Academy of Dermatology and Venereology Congress, held September 25-28, 2024, in Amsterdam.²

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The SHINE phase 2b study was a prospective, randomized, double-blind, placebo-controlled trial conducted across multiple centers, enrolling 177 patients with moderate to severe HS. The study results, initially released in 2019, demonstrated vilobelimab’s efficacy in reducing inflammatory lesions such as abscesses and nodules.

In the newly released post hoc analysis, researchers examined additional clinical endpoints, focusing particularly on vilobelimab’s ability to reduce draining tunnels.

The study also evaluated the total lesion count, incorporating abscesses, nodules, and draining tunnels, and the International Hidradenitis Suppurativa Score 4 (IHS4). Additionally, a modified version of the Hidradenitis Suppurativa Clinical Response (HiSCR) was introduced, placing more emphasis on the reduction of draining tunnels.

At 16 weeks, vilobelimab 1200 mg showed a statistically significant placebo-adjusted reduction in key outcomes. Treatment with vilobelimab resulted in a 45.2% reduction in draining tunnels and a 25.1% reduction in abscesses, nodules, and draining tunnels combined.

Vilobelimab also led to a 31.6% reduction in IHS4, reflecting an overall improvement in disease severity.

The modified HiSCR assessment proved to be an important measure in this study. Traditionally, HiSCR evaluates reductions in abscesses and nodules, but the modified version extends its focus to include draining tunnels, which are often resistant to treatment and significantly affect quality of life.

"The results of this post hoc analysis shine a spotlight on the role of C5a/C5aR signaling in driving inflammation in HS and demonstrate vilobelimab’s potential not only to reduce abscesses and nodules but, critically, to target draining tunnels as well," said Camilla Chong, MD, chief medical officer of InflaRx.¹

Vilobelimab works by inhibiting C5a, a key mediator in the complement system that plays a significant role in inflammation. By targeting C5a, the drug reduces immune cell recruitment to inflammatory sites, thus diminishing tissue damage and lesion formation.

InflaRx is also exploring the potential of C5a receptor inhibitors, such as INF904, to further address HS and other inflammatory conditions, building on the positive results of vilobelimab.

References

1. InflaRx presents post hoc analysis of SHINE trial of vilobelimab in hidradenitis suppurativa at the 2024 European Academy of Dermatology and Venereology Congress. News release. Yahoo Finance. September 25, 2024. Accessed September 25, 2024. https://finance.yahoo.com/news/inflarx-presents-post-hoc-analysis-113000250.html
2. Giamarellos-Bourboulis EJ, Sayed C, Weisman J, et al. Vilobelimab demonstrates significant improvement in reduction of draining tunnels, total lesion count, International Hidradenitis Suppurativa Score 4 and the newly introduced modified-HiSCR: a post hoc analysis of the Phase IIb SHINE study. Poster presented at: 2024 EADV Congress; September 25-28, 2024; Amsterdam.