InflaRx to Present New Preclinical Data on INF904 at the 19th European Meeting on Complement in Human Diseases
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, will present preclinical data on INF904, their novel oral C5aR inhibitor, at the 2024 European Meeting on Complement in Human Diseases (EMCHD) in Lübeck, Germany, from September 2-6, 2024. The company will showcase two poster presentations, participate in a C5a/C5aR-focused panel discussion, and speak at a satellite symposium.
INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has demonstrated anti-inflammatory effects in preclinical models. A first-in-human study showed that INF904 is well-tolerated and exhibits no safety concerns in single doses from 3 mg to 240 mg or multiple doses from 30 mg QD to 90 mg BID for 14 days. The drug achieved ≥90% blockade of C5a-induced neutrophil activation over the 14-day dosing period, supporting its potential as a best-in-class treatment.
InflaRx N.V. (Nasdaq: IFRX), un'azienda biofarmaceutica specializzata in terapie anti-infiammatorie, presenterà dati preclinici su INF904, il loro nuovo inibitore orale del C5aR, al 2024 European Meeting on Complement in Human Diseases (EMCHD) a Lübeck, Germania, dal 2 al 6 settembre 2024. L'azienda presenterà due poster, parteciperà a una tavola rotonda focalizzata su C5a/C5aR e parlerà a un simposio satellitare.
INF904 è un inibitore a piccole molecole, somministrato per via orale, del recettore C5a che ha dimostrato effetti anti-infiammatori in modelli preclinici. Uno studio di prima somministrazione nell'uomo ha mostrato che INF904 è ben tollerato e non presenta problemi di sicurezza per dosi singole da 3 mg a 240 mg o dosi multiple da 30 mg una volta al giorno fino a 90 mg due volte al giorno per 14 giorni. Il farmaco ha raggiunto un blocco ≥90% dell'attivazione dei neutrofili indotta da C5a durante il periodo di somministrazione di 14 giorni, supportando il suo potenziale come trattamento di prima classe.
InflaRx N.V. (Nasdaq: IFRX), una empresa biofarmacéutica enfocada en terapias antiinflamatorias, presentará datos preclínicos sobre INF904, su novedoso inhibidor oral del C5aR, en la 2024 European Meeting on Complement in Human Diseases (EMCHD) en Lübeck, Alemania, del 2 al 6 de septiembre de 2024. La empresa mostrará dos presentaciones en cartel, participará en una discusión en panel centrada en C5a/C5aR y dará una charla en un simposio satelital.
INF904 es un inhibidor de pequeñas moléculas administrado por vía oral del receptor C5a que ha demostrado efectos antiinflamatorios en modelos preclínicos. Un estudio de primera en humanos mostró que INF904 es bien tolerado y no presenta inquietudes de seguridad en dosis únicas de 3 mg a 240 mg o dosis múltiples de 30 mg al día a 90 mg dos veces al día durante 14 días. El fármaco logró un bloqueo del ≥90% de la activación de neutrófilos inducida por C5a durante el período de dosificación de 14 días, apoyando su potencial como tratamiento de primera clase.
InflaRx N.V. (Nasdaq: IFRX), 항염증 치료제에 중점을 둔 생명공학 회사는 2024 유럽 보체 및 인간 질병 회의 (EMCHD)에서 INF904에 대한 전임상 데이터를 발표할 예정입니다. 이 회의는 독일 뤼벡에서 2024년 9월 2일부터 6일까지 열립니다. 회사는 두 개의 포스터 발표를 하고, C5a/C5aR에 관한 패널 토론에 참여하며, 위성 심포지엄에서 발표할 것입니다.
INF904는 C5a 수용체의 경구 투여가 가능한 소분자 억제제로, 전임상 모델에서 항염증 효과를 입증하였습니다. 첫 번째 인간 연구에서는 INF904가 사람에게 잘 견뎌지며, 3 mg에서 240 mg까지의 단일 투여량이나 14일 동안 30 mg 1일 1회에서 90 mg 1일 2회 투여 시 안전성 문제가 없음을 보여주었습니다. 이 약물은 14일의 투여 기간 동안 C5a에 의해 유도된 호중구 활성화를 ≥90% 차단하여, 일급 치료제로서의 잠재력을 지지하고 있습니다.
InflaRx N.V. (Nasdaq: IFRX), une entreprise biopharmaceutique spécialisée dans les traitements anti-inflammatoires, présentera des données précliniques sur INF904, leur nouvel inhibiteur oral du C5aR, lors de la 2024 European Meeting on Complement in Human Diseases (EMCHD) à Lübeck, en Allemagne, du 2 au 6 septembre 2024. L'entreprise présentera deux affiches, participera à une discussion en panel axée sur C5a/C5aR et interviendra lors d'un symposium satellite.
INF904 est un inhibiteur de petites molécules administré par voie orale du récepteur C5a, qui a démontré des effets anti-inflammatoires dans des modèles précliniques. Une première étude sur l'homme a montré qu'INF904 est bien toléré et ne présente aucun problème de sécurité pour des doses uniques allant de 3 mg à 240 mg ou des doses multiples de 30 mg une fois par jour à 90 mg deux fois par jour pendant 14 jours. Le médicament a atteint un blocage de ≥90% de l'activation des neutrophiles induite par C5a pendant la période de dosage de 14 jours, soutenant son potentiel en tant que traitement de classe supérieure.
InflaRx N.V. (Nasdaq: IFRX), ein biopharmazeutisches Unternehmen, das sich auf entzündungshemmende Therapeutika konzentriert, wird präklinische Daten zu INF904, ihrem neuartigen oralen C5aR-Inhibitor, auf dem 2024 European Meeting on Complement in Human Diseases (EMCHD) in Lübeck, Deutschland, vom 2. bis 6. September 2024 präsentieren. Das Unternehmen wird zwei Posterpräsentationen zeigen, an einer Paneldiskussion zu C5a/C5aR teilnehmen und auf einem Satellitensymposium sprechen.
INF904 ist ein oral verabreichbarer, niedermolekularer Inhibitor des C5a-Rezeptors, der in präklinischen Modellen entzündungshemmende Wirkungen gezeigt hat. Eine erste Studie am Menschen zeigte, dass INF904 gut verträglich ist und bei Einzeldosen von 3 mg bis 240 mg oder mehreren Dosen von 30 mg täglich bis 90 mg zweimal täglich über 14 Tage keine Sicherheitsbedenken aufweist. Das Medikament erreichte eine ≥90%ige Blockade der durch C5a induzierten Aktivierung von Neutrophilen während des 14-tägigen Dosierungszeitraums, was sein Potenzial als Best-in-Class-Behandlung unterstützt.
- INF904 demonstrated anti-inflammatory effects in preclinical disease models
- First-in-human study showed INF904 is well-tolerated with no safety concerns
- INF904 achieved ≥90% blockade of C5a-induced neutrophil activation over 14 days
- INF904 shows minimal inhibition of CYP3A4/5 enzymes, potentially reducing drug interactions
- None.
JENA, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced it will present preclinical data on the company’s novel oral C5aR inhibitor, INF904, at the 2024 European Meeting on Complement in Human Diseases (EMCHD) being held in Lübeck, Germany, September 2 – 6, 2024. In addition to two poster presentations, InflaRx representatives will participate in a C5a/C5aR-focused panel discussion as well as speak at a satellite symposium.
EMCHD 2024 will focus on emerging developments in the complement field with a goal of translating basic scientific advancements into meaningful new therapeutic approaches to combat human diseases. A preliminary conference program can be found here. Given the company’s commitment to advancing science to treat complement-mediated conditions, InflaRx is also one of the corporate sponsors of this year’s meeting.
Poster Presentations
Poster title: INF904, a novel oral C5a receptor 1 (C5aR1) antagonist, shows promising therapeutic effects in inflammatory disease models
Poster number: P19
Authors: Zhongli Xu, Rui Liu, Ophelia Chen, Bruce P. Burnett, Maria Habel, Renfeng Guo
Poster title: Preclinical pharmacological characterization of INF904, an oral small molecule antagonist to complement 5a receptor1 (C5aR1)
Poster number: P20
Authors: Rui Liu, Zhongli Xu, Ophelia Chen, Bruce P. Burnett, Maria Habel, Renfeng Guo
Other Sessions
Satellite symposium - oral session: Inhibition of the C5a/C5aR1 axis in inflammation
Speaker: Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx
Day/time: Monday, September 2, 3:00 – 3:30 pm CET
Satellite symposium - panel discussion: Targeting C3 and/or C5 Pathways
InflaRx participant: Prof. Niels C. Riedemann
Day/time: Monday, September 2, 4:00 – 5:00 pm CET
Lunch seminar: Complement C5a/C5aR inhibition in human disease with best-in-class inhibitors
InflaRx speakers:
Prof. Niels C. Riedemann, Chief Executive Officer and Founder
Dr. Renfeng Guo, Chief Scientific Officer and Founder
Dr. Camilla Chong, Chief Medical Officer
Day/time: Tuesday, September 3, 1:00 – 1:45 pm CET
About INF904
INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that INF904 is well tolerated in treated subjects and exhibits no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days. Pharmacokinetic / pharmacodynamic data support best-in-class potential of INF904 with a ≥
About InflaRx
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, 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.
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
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 and current expectations concerning, among other things, our ability to successfully commercialize and the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 patients by U.S. hospitals, our ability to positively influence treatment recommendations by medical/healthcare institutes, guideline bodies and other third-party organizations; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under the EUA, and in the future if approved for commercial use in the United States or elsewhere; our ability to successfully implement The InflaRx Commitment Program and estimate future write-downs due to expiry and costs in the event of the price refunds, the success of our future clinical trials for vilobelimab's treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including ARDS, PG, and any other product candidates, including INF904, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of preclinical studies and clinical trials of vilobelimab, INF904 and any other product candidates, including for the development of vilobelimab in several indications, including to treat PG, HS and CSU and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with and the receptiveness and approval by regulators regarding the results of clinical trials and potential regulatory approval or authorization pathways including related to our MAA submission for vilobelimab and our BLA for GOHIBIC (vilobelimab); the timing and outcome of any discussions or submission of filings for regulatory approval or authorization of vilobelimab, INF904 or any other product candidate, and the timing of and our ability to obtain and maintain full regulatory approval or the EUA, of vilobelimab or GOHIBIC (vilobelimab) for any indication; our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, INF904 and any other product candidates, and the scope of such protection; whether the FDA, or the EMA or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; the success of our future clinical trials for vilobelimab, INF904 and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; our expectations regarding the size of the patient populations for, the market opportunity for, the medical need for and clinical utility of vilobelimab, INF904 or any other product candidates, if approved or authorized for commercial use; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our expectations regarding the scope of any approved indication for vilobelimab; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if, approved or authorized, any commercial sales; if any of our product candidates obtain regulatory approval or authorization, our ability to comply with and satisfy ongoing drug regulatory obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval or authorization and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors and other therapeutic products being developed in similar medical conditions in which vilobelimab, INF904 or any other of our product candidates is being developed or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” 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.
FAQ
What is INF904 and what is its purpose?
What are the key findings from the INF904 first-in-human study?
When and where will InflaRx present the INF904 preclinical data?
What advantage does INF904 have over other C5aR inhibitors?
