Anti-C5a Antibody Vilobelimab for HS to Be Presented at EADV
InflaRx N.V. announced the e-poster presentation of a post hoc analysis of the SHINE Phase 2b study of its first-in-class anti-C5a antibody, vilobelimab, in hidradenitis suppurativa (HS) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, Netherlands, from September 25-28.
“This analysis sheds significant light on the role of C5a/C5aR signaling and vilobelimab’s ability to address the underlying inflammation driving hidradenitis suppurativa (HS), including its potential to reduce not only abscesses and nodules, but draining tunnels that remain a significant burden for many patients with this debilitating disease,” Camilla Chong, MD, Chief Medical Officer of InflaRx, said. “In addition, we believe exploring additional efficacy parameters for HS in addition to HiSCR (Hidradenitis Suppurativa Clinical Response) could lead to a greater understanding of the disease-modifying potential of C5a inhibitors such as vilobelimab and C5aR inhibitors such as INF904, particularly with regard to reducing draining tunnels.”
The e-poster (P0063) is summarized here:
Title: 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
Authors: Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Jamie Weisman, Jacek Szepietowski, Falk Bechara, Niels C. Riedemann, Camilla Chong, Hoda Tawfik
SHINE was a prospective, randomized, placebo-controlled, double-blind multicenter Phase 2b trial in 177 patients with moderate to severe HS, with results announced in 2019. The post hoc analysis presented at EADV 2024 looked at other important clinical efficacy endpoints and, in particular vilobelimab 1200 mg, which was statistically significant compared to placebo at 16 weeks. Efficacy parameters assessed included the reduction of draining tunnels (dT), reduction of total lesion counts (abscesses + nodules + draining tunnels (ANdT)) and the International Hidradenitis Suppurativa Score 4 (IHS4) compared to placebo.
In this post hoc analysis, vilobelimab 1200 mg demonstrated a placebo-adjusted significant reduction in dT, ANdT, and IHS4 of 45.2%, 25.1% and 31.6%, respectively. InflaRx believes this analysis suggests meaningful clinical benefit for vilobelimab in HS. Further, it supports utilizing a modified version of the HiSCR that measures drug activity against all three lesion types with an emphasis on the reduction of dT, a critical manifestation of the disease that greatly impacts patients’ quality of life.