InflaRx Presents Post Hoc Analysis of SHINE Trial of Vilobelimab in Hidradenitis Suppurativa at the 2024 European Academy of Dermatology and Venereology Congress
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.
InflaRx ha presentato un'analisi post hoc dello studio SHINE fase 2b su vilobelimab nell'hidradenitis suppurativa (HS) al Congresso EADV 2024. L'analisi si è concentrata sulla dose di 1200 mg, che ha mostrato miglioramenti significativi rispetto al placebo dopo 16 settimane:
- Riduzione del 45,2% dei tunnel drenanti
- Riduzione del 25,1% del conteggio totale delle lesioni
- Riduzione del 31,6% nel punteggio 4 dell'International Hidradenitis Suppurativa Score
Questi risultati suggeriscono benefici clinici significativi per vilobelimab nell'HS e supportano l'uso di una versione modificata del HiSCR che misura l'attività del farmaco contro tutti e tre i tipi di lesione, enfatizzando la riduzione dei tunnel drenanti. L'azienda ritiene che questa analisi fornisca informazioni sul potenziale di vilobelimab nell'affrontare l'infiammazione sottostante nell'HS.
InflaRx presentó un análisis post hoc del estudio SHINE fase 2b sobre vilobelimab en hidradenitis supurativa (HS) en el Congreso EADV 2024. El análisis se centró en la dosis de 1200 mg, que mostró mejoras significativas en comparación con el placebo a las 16 semanas:
- Reducción del 45,2% en los túneles de drenaje
- Reducción del 25,1% en el conteo total de lesiones
- Reducción del 31,6% en la puntuación 4 del International Hidradenitis Suppurativa Score
Estos resultados sugieren beneficios clínicos significativos para vilobelimab en HS y apoyan el uso de una versión modificada del HiSCR que mide la actividad del fármaco contra los tres tipos de lesiones, enfatizando la reducción de túneles de drenaje. La empresa cree que este análisis proporciona información sobre el potencial de vilobelimab para abordar la inflamación subyacente en HS.
InflaRx는 2024 EADV Congress에서 vilobelimab의 히드라데니티스 수푸라티바 (HS)에 대한 SHINE 2b 단계 연구의 후속 분석 결과를 발표했습니다. 이 분석은 1200 mg 용량에 중점을 두었으며, 16주 후 위약과 비교하여 상당한 개선을 보였습니다:
- 배출 터널에서 45.2% 감소
- 총 병변 수에서 25.1% 감소
- 국제 히드라데니티스 수푸라티바 점수 4에서 31.6% 감소
이러한 결과는 HS의 vilobelimab에 대한 의미 있는 임상적 이점을 제시하며, 모든 세 가지 병변 유형에 대한 약물 활성을 측정하는 수정된 HiSCR 버전의 사용을 지원합니다. 이 회사는 이 분석이 HS에서 기저 염증을 해결하는 vilobelimab의 잠재력에 대한 통찰력을 제공한다고 믿고 있습니다.
InflaRx a présenté une analyse post hoc de l'étude SHINE Phase 2b sur vilobelimab dans la hidradenitis suppurativa (HS) lors du Congrès EADV 2024. L'analyse s'est concentrée sur la dose de 1200 mg, qui a montré des améliorations significatives par rapport au placebo après 16 semaines :
- Réduction de 45,2 % des tunnels de drainage
- Réduction de 25,1 % du nombre total de lésions
- Réduction de 31,6 % dans le score 4 de l'International Hidradenitis Suppurativa Score
Ces résultats suggèrent des bénéfices cliniques significatifs pour vilobelimab dans HS et soutiennent l'utilisation d'une version modifiée du HiSCR qui mesure l'activité du médicament contre les trois types de lésions, en mettant l'accent sur la réduction des tunnels de drainage. L'entreprise estime que cette analyse fournit des informations sur le potentiel de vilobelimab pour traiter l'inflammation sous-jacente dans HS.
InflaRx hat beim EADV-Kongress 2024 eine post-hoc-Analyse der SHINE-Studie der Phase 2b zu vilobelimab bei Hidradenitis suppurativa (HS) vorgestellt. Die Analyse konzentrierte sich auf die Dosis von 1200 mg, die im Vergleich zu Placebo nach 16 Wochen signifikante Verbesserungen zeigte:
- 45,2% Reduktion der drainage Tunnels
- 25,1% Reduktion der Gesamtzahl der Läsionen
- 31,6% Reduktion im International Hidradenitis Suppurativa Score 4
Diese Ergebnisse deuten auf bedeutende klinische Vorteile von vilobelimab bei HS hin und unterstützen die Verwendung einer modifizierten Version des HiSCR, die die Wirkungsweise des Medikaments gegen alle drei Läsionstypen misst und die Reduktion der drainage Tunnels betont. Das Unternehmen ist der Ansicht, dass diese Analyse Einblicke in das Potenzial von vilobelimab zur Bekämpfung von zugrunde liegender Entzündung bei HS bietet.
- 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
- None.
Insights
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 tunnels25.1% reduction in total lesion count31.6% 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
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?
How does vilobelimab (IFRX) potentially benefit patients with hidradenitis suppurativa?
What is the significance of the draining tunnel reduction shown in InflaRx's SHINE trial analysis?
When and where did InflaRx present the post hoc analysis of the SHINE trial for vilobelimab (IFRX)?
