InflaRx Shares SHINE Trial Analysis of Vilobelimab in Hidradenitis Suppurativa at 2024 EADV Congress

InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company based in Jena, Germany, is making significant strides in the development of anti-inflammatory therapeutics targeting the complement system. The company recently shared findings from a post hoc analysis of its SHINE Phase 2b study on vilobelimab, their pioneering anti-C5a antibody, at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam. This analysis provides new insights into the effectiveness of vilobelimab in treating hidradenitis suppurativa (HS), a chronic skin condition characterized by painful abscesses and nodules.

Dr. Camilla Chong, the Chief Medical Officer at InflaRx, emphasized the importance of these findings. She noted that the analysis highlights the critical role of C5a/C5aR signaling in HS and vilobelimab’s potential to significantly alleviate the symptoms. This includes not only reducing abscesses and nodules but also addressing draining tunnels, which are particularly troublesome for patients. Dr. Chong further suggested that by examining additional efficacy parameters beyond the standard HiSCR (Hidradenitis Suppurativa Clinical Response), a more comprehensive understanding of the disease-modifying capabilities of C5a inhibitors like vilobelimab and C5aR inhibitors such as INF904 could be gained.

The SHINE study was a prospective, randomized, placebo-controlled, double-blind multicenter Phase 2b trial involving 177 patients with moderate to severe HS. The post hoc analysis, presented at the EADV 2024, focused on a subset of clinical efficacy endpoints, particularly the 1200 mg dosage of vilobelimab, which showed statistically significant results compared to placebo after 16 weeks. The parameters evaluated included the reduction of draining tunnels (dT), the total lesion counts (abscesses, nodules, draining tunnels - ANdT), and the International Hidradenitis Suppurativa Score 4 (IHS4).

The analysis revealed that vilobelimab 1200 mg led to a significant placebo-adjusted reduction in dT, ANdT, and IHS4 by 45.2%, 25.1%, and 31.6%, respectively. InflaRx believes these results indicate a meaningful clinical benefit of vilobelimab in treating HS. Additionally, the findings support the use of a modified HiSCR that assesses the drug's effectiveness against all three lesion types with a particular focus on reducing draining tunnels, a symptom that severely impacts patients' quality of life.

Vilobelimab is a first-in-class monoclonal antibody that targets human complement factor C5a. It effectively blocks C5a’s biological activity while selectively preserving the formation of the membrane attack complex (C5b-9), crucial for immune defense. Pre-clinical studies have shown that vilobelimab can control inflammation-driven tissue and organ damage by inhibiting C5a, a key amplifier of inflammatory responses. Beyond HS, vilobelimab is also being developed for other inflammatory conditions, including pyoderma gangrenosum (PG) and COVID-19.

In April 2023, the FDA granted Emergency Use Authorization (EUA) for vilobelimab (marketed as GOHIBIC) for treating COVID-19 in hospitalized adults who require invasive mechanical ventilation or extracorporeal membrane oxygenation. InflaRx also launched The InflaRx Commitment Program in January 2024, offering refunds for up to six inpatient doses of GOHIBIC for eligible institutions treating COVID-19 patients in intensive care who subsequently died.

Moreover, the Marketing Authorization Application (MAA) for vilobelimab in treating adults with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) is under review by the European Committee for Medicinal Products for Human Use. This application covers all 27 European Union member states.

InflaRx, founded in 2007, continues to innovate in the field of anti-inflammatory therapeutics with offices and subsidiaries in Jena and Munich, Germany, and Ann Arbor, Michigan, USA. The company's lead product candidate, vilobelimab, has shown promising disease-modifying clinical activity and tolerability across various indications, demonstrating its potential to address significant unmet medical needs in inflammatory diseases.