InflaRx to Showcase Vilobelimab’s Role in Immuno-Dermatology at the 2025 AAD Annual Meeting
InflaRx N.V. (Nasdaq: IFRX) announced that all their submitted abstracts featuring vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS) have been accepted for presentation at the 2025 American Academy of Dermatology Annual Meeting in Orlando, FL.
The presentations include first-time data on reduction in draining tunnels with vilobelimab in HS patients, and insights on a modified HiSCR scoring system. The abstracts cover safety studies, pharmacokinetic/pharmacodynamic analyses, and efficacy data from Phase 2 trials in both PG and HS conditions.
Vilobelimab, a first-in-class monoclonal anti-human complement factor C5a antibody, is currently in Phase 3 trials for PG and has received orphan drug designation from both FDA and EMA, plus FDA fast track designation for PG treatment.
InflaRx N.V. (Nasdaq: IFRX) ha annunciato che tutti i loro abstract presentati riguardanti vilobelimab nel trattamento della gangrena cutanea (PG) e dell'idrosadenite suppurativa (HS) sono stati accettati per la presentazione al 2025 American Academy of Dermatology Annual Meeting a Orlando, FL.
Le presentazioni includono dati inediti sulla riduzione dei tunnel drenanti nei pazienti con HS trattati con vilobelimab, e approfondimenti su un sistema di punteggio HiSCR modificato. Gli abstract coprono studi di sicurezza, analisi farmacocinetiche/farmacodinamiche e dati di efficacia provenienti da studi di Fase 2 sia per PG che per HS.
Vilobelimab, un anticorpo monoclonale di prima classe contro il fattore C5a del complemento umano, è attualmente in studi di Fase 3 per PG e ha ricevuto la designazione di farmaco orfano sia dalla FDA che dall'EMA, oltre alla designazione di percorso accelerato della FDA per il trattamento della PG.
InflaRx N.V. (Nasdaq: IFRX) anunció que todos sus resúmenes presentados sobre vilobelimab en la gangrena piodérmica (PG) y la hidradenitis supurativa (HS) han sido aceptados para su presentación en el 2025 American Academy of Dermatology Annual Meeting en Orlando, FL.
Las presentaciones incluyen datos inéditos sobre la reducción de túneles drenantes en pacientes con HS tratados con vilobelimab, así como información sobre un sistema de puntuación HiSCR modificado. Los resúmenes abarcan estudios de seguridad, análisis farmacocinéticos/farmacodinámicos y datos de eficacia de ensayos de Fase 2 tanto en PG como en HS.
Vilobelimab, un anticuerpo monoclonal de primera clase contra el factor C5a del complemento humano, se encuentra actualmente en ensayos de Fase 3 para PG y ha recibido la designación de medicamento huérfano tanto de la FDA como de la EMA, además de la designación de vía rápida de la FDA para el tratamiento de PG.
InflaRx N.V. (Nasdaq: IFRX)는 vilobelimab을 이용한 화농성 궤양증(PG) 및 한선염(HS) 관련 모든 초록이 2025 American Academy of Dermatology Annual Meeting에서 발표될 것이라고 발표했습니다. 장소는 플로리다주 올랜도입니다.
발표 내용에는 HS 환자에서 vilobelimab을 사용한 배수 터널 감소에 대한 최초의 데이터와 수정된 HiSCR 점수 시스템에 대한 통찰이 포함되어 있습니다. 초록은 안전성 연구, 약리학적/약물 동역학 분석 및 PG와 HS 모두에서의 2상 시험의 효능 데이터를 다룹니다.
Vilobelimab은 인간 보완 인자 C5a에 대한 최초의 단클론 항체로 현재 PG에 대해 3상 시험 중이며, FDA와 EMA 모두에서 희귀의약품 지정을 받았으며, PG 치료를 위한 FDA의 신속 승인 지정을 받았습니다.
InflaRx N.V. (Nasdaq: IFRX) a annoncé que tous leurs résumés soumis concernant vilobelimab dans le traitement de la gangrène pyodermique (PG) et de l'hydradénite suppurative (HS) ont été acceptés pour présentation lors de la 2025 American Academy of Dermatology Annual Meeting à Orlando, FL.
Les présentations incluent des données inédites sur la réduction des tunnels de drainage chez les patients atteints de HS traités avec vilobelimab, ainsi que des éclaircissements sur un système de notation HiSCR modifié. Les résumés couvrent des études de sécurité, des analyses pharmacocinétiques/pharmacodynamiques et des données d'efficacité provenant des essais de Phase 2 tant pour PG que pour HS.
Vilobelimab, un anticorps monoclonal de première classe contre le facteur C5a du complément humain, est actuellement en essais de Phase 3 pour PG et a reçu la désignation de médicament orphelin de la part de la FDA et de l'EMA, ainsi qu'une désignation de voie rapide de la FDA pour le traitement du PG.
InflaRx N.V. (Nasdaq: IFRX) gab bekannt, dass alle eingereichten Abstracts zu vilobelimab bei pyodermatischer Gangrän (PG) und Hidradenitis Suppurativa (HS) zur Präsentation auf dem 2025 American Academy of Dermatology Annual Meeting in Orlando, FL, akzeptiert wurden.
Die Präsentationen umfassen erstmalige Daten zur Reduktion von Drainagetunneln bei HS-Patienten, die mit vilobelimab behandelt wurden, sowie Einblicke in ein modifiziertes HiSCR-Bewertungssystem. Die Abstracts decken Sicherheitsstudien, pharmakokinetische/pharmakodynamische Analysen und Wirksamkeitsdaten aus Phase-2-Studien sowohl zu PG als auch zu HS ab.
Vilobelimab, ein Antikörper der ersten Klasse gegen den menschlichen Komplementfaktor C5a, befindet sich derzeit in Phase-3-Studien für PG und hat sowohl von der FDA als auch von der EMA die Orphan-Drug-Bezeichnung erhalten, sowie eine beschleunigte Zulassung der FDA für die Behandlung von PG.
- All submitted abstracts accepted for AAD 2025 presentation
- Phase 3 trial ongoing for pyoderma gangrenosum
- FDA fast track designation received
- Dual orphan drug designation from FDA and EMA
- None.
JENA, Germany, Feb. 28, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced acceptance of all submitted abstracts, featuring the role of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS), to be presented during the 2025 American Academy of Dermatology (AAD) Annual Meeting, March 7 - 11, in Orlando, FL.
Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: “We are proud to announce that all of our submitted abstracts have been accepted for presentation at the AAD Annual Meeting, reflecting the considerable scientific work that has gone into the clinical development of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS). In HS, we are presenting for the first time the reduction in draining tunnels (dTs) with vilobelimab, and the relevance of our modified HiSCR which weighs the importance of these dTs which have a devastating impact on patients with HS.”
#63560
Oral poster presentation: Vilobelimab Safety in Pyoderma Gangrenosum Patients: A Phase 2a Explorative Dose-Finding Study
Authors: Afsaneh Alavi, Benjamin H. Kaffenberger, Hoda Tawfik, Camilla Chong, Bruce P. Burnett
Date/time: Mar 8, 2025 10:15 AM - 10:20 AM
#63550
ePoster: Pharmacokinetic/Pharmacodynamic Analysis of Vilobelimab and Complement C3 and C5a in a Randomized, Controlled Multidose Phase 2a Study in Pyoderma Gangrenosum
Authors: Afsaneh Alavi, Hoda Tawfik, Camilla Chong, Joseph F. Grippo, Bruce P. Burnett
#63490
ePoster: Reduction in Draining Tunnels in Hidradenitis Suppurativa Patients Treated with Vilobelimab in a Randomized, Placebo-Controlled, Double-Blind Multicenter Phase 2b Study
Authors: Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Jamie Weisman, Jacek C Szepietowski, Falk Bechara, Hoda Tawfik, Camilla Chong, Bruce P. Burnett
#63505
ePoster: Vilobelimab Post-hoc Efficacy in Hidradenitis Suppurativa using the Modified-HiSCR with Data from the Phase 2b SHINE Study
Authors: Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Camilla Chong, Hoda Tawfik, Bruce P. Burnett
#63527
ePoster: Vilobelimab Safety in Hidradenitis Suppurativa Patients in a Randomized, Placebo-Controlled, Double-Blind Multicenter Phase 2b study
Authors: Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Jamie Weisman, Jacek C Szepietowski, Falk Bechara, Hoda Tawfik, Camilla Chong, Bruce P. Burnett
#63454
ePoster: Pharmacokinetic/Pharmacodynamic Analysis of Vilobelimab Demonstrates a Significant Reduction of C5a Levels in Hidradenitis Suppurativa Patients
Authors: Evangelos J. Giamarellos-Bourboulis, Theodora Kanni, Hoda Tawfik, Camilla Chong, Joe F. Grippo, Bruce P. Burnett
About Vilobelimab
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which targets the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Unlike upstream blockers e.g. anti-C5, vilobelimab does not alter the membrane attack complex (C5b-9). Thus, vilobelimab leaves the formation of the 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.
Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including a Phase 3 trial for pyoderma gangrenosum (PG). Vilobelimab has been granted orphan drug designation for the treatment of PG by both the FDA and the EMA, as well as fast track designation by the FDA.
About GOHIBIC (vilobelimab)
In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO. The emergency use of GOHIBIC is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.
GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC website http://www.gohibic.com.
In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of
A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC’s approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.
The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.
About InflaRx N.V.
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 |
FORWARD-LOOKING STATEMENTS
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FAQ
What clinical trial results will InflaRx (IFRX) present at AAD 2025 for vilobelimab?
What regulatory designations has vilobelimab received for pyoderma gangrenosum treatment?
How does vilobelimab's mechanism of action differ from other complement inhibitors?
What is the current development stage of vilobelimab for pyoderma gangrenosum?
