InflaRx Presents Post Hoc Analysis of SHINE Trial of Vilobelimab in Hidradenitis Suppurativa at the 2024 European Academy of Dermatology and Venereology Congress

Rhea-AI Summary

InflaRx presented a post hoc analysis of the SHINE Phase 2b study of vilobelimab in hidradenitis suppurativa (HS) at the 2024 EADV Congress. The analysis focused on the 1200 mg dose, which showed significant improvements compared to placebo at 16 weeks:

- 45.2% reduction in draining tunnels
- 25.1% reduction in total lesion count
- 31.6% reduction in International Hidradenitis Suppurativa Score 4

These results suggest meaningful clinical benefits for vilobelimab in HS and support using a modified version of the HiSCR that measures drug activity against all three lesion types, emphasizing the reduction of draining tunnels. The company believes this analysis provides insights into vilobelimab's potential to address underlying inflammation in HS.

Positive

• Vilobelimab 1200 mg showed significant improvements in multiple HS efficacy parameters compared to placebo
• 45.2% reduction in draining tunnels, a critical manifestation impacting patients' quality of life
• 25.1% reduction in total lesion count (abscesses + nodules + draining tunnels)
• 31.6% reduction in International Hidradenitis Suppurativa Score 4
• Results suggest meaningful clinical benefit for vilobelimab in HS

Negative

• None.

Insights

Medical Research Analyst

This post hoc analysis of the SHINE Phase 2b study provides valuable insights into vilobelimab's potential in treating hidradenitis suppurativa (HS). The data shows significant improvements in key efficacy parameters:

• 45.2% reduction in draining tunnels
• 25.1% reduction in total lesion count
• 31.6% reduction in International Hidradenitis Suppurativa Score 4

These results suggest vilobelimab may offer meaningful clinical benefits, particularly in addressing draining tunnels - a critical aspect of HS that significantly impacts patients' quality of life. The analysis also supports exploring modified efficacy measures beyond the standard HiSCR, which could better capture the drug's disease-modifying potential.

While promising, it's important to note this is a post hoc analysis of a Phase 2b trial. Further studies, particularly a Phase 3 trial, would be needed to confirm these findings and potentially support regulatory approval for HS. The market for HS treatments is growing and if vilobelimab continues to show efficacy, it could become a valuable option for patients with this debilitating condition.

JENA, Germany, Sept. 25, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today 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, September 25 – 28, 2024.

Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: “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. 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.”

E-poster: P0063

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.

About GOHIBIC (vilobelimab)

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG).

In April 2023, the FDA issued the EUA for GOHIBIC (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). In January 2024, InflaRx announced the launch of The InflaRx Commitment Program, pursuant to which the cost of GOHIBIC (vilobelimab) will be refunded for up to six (6) administered inpatient doses (the full treatment course) to institutions that meet the eligibility requirements, for patients who were administered GOHIBIC (vilobelimab) in line with its EUA and who died due to COVID-19 in the intensive care unit.

The Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO is under regulatory review by the European Committee for Medicinal Products for Human Use under the centralized procedure, which applies to all 27 member states of the European Union.

About InflaRx

InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered, small molecule inhibitor of the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.com.

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

Contacts:

InflaRx N.V.	MC Services AG
Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de	Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752

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FAQ

What were the key findings of InflaRx's post hoc analysis of the SHINE trial for vilobelimab in HS?

The post hoc analysis of the SHINE trial showed that vilobelimab 1200 mg demonstrated significant improvements compared to placebo at 16 weeks, including a 45.2% reduction in draining tunnels, 25.1% reduction in total lesion count, and 31.6% reduction in International Hidradenitis Suppurativa Score 4.

How does vilobelimab (IFRX) potentially benefit patients with hidradenitis suppurativa?

Vilobelimab shows potential to address the underlying inflammation in HS by reducing not only abscesses and nodules but also draining tunnels, which are a significant burden for many patients. The analysis suggests meaningful clinical benefits and supports exploring additional efficacy parameters beyond the current HiSCR measure.

What is the significance of the draining tunnel reduction shown in InflaRx's SHINE trial analysis?

The 45.2% reduction in draining tunnels is significant because draining tunnels are a critical manifestation of hidradenitis suppurativa that greatly impacts patients' quality of life. This reduction suggests vilobelimab's potential to address an important aspect of the disease.

When and where did InflaRx present the post hoc analysis of the SHINE trial for vilobelimab (IFRX)?

InflaRx presented the post hoc analysis of the SHINE trial for vilobelimab in hidradenitis suppurativa at the 2024 European Academy of Dermatology and Venereology (EADV) Congress held in Amsterdam, September 25-28, 2024.