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Jena, Germany, February 28, 2025 – 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 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine.
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.
Jan Medina, CFA
Vice President, Head of Investor Relations
Email: IR@inflarx.de
MC Services AG
Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email: inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +1-339-832-0752
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the headings, “Risk factors” and “Cautionary statement regarding forward looking statements”, in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.