IFRX InflaRx NV

InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced the presentation of preclinical data for 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.

Members of InflaRx leadership also participated in a satellite symposium highlighting the role of the C5a/C5aR1 axis in driving inflammation and served as the biopharma industry representative on a panel focused on the relevance of targeting C3 and C5. InflaRx also hosted a lunch seminar focused on C5a/C5aR inhibition in human disease with best-in-class compounds.

Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: “We welcome the opportunity to demonstrate our commitment to advancing the science of complement inhibition and progress toward our goal of developing first-in-class and best-in-class anti-inflammatory therapies via inhibition of C5a and C5aR. The preclinical findings presented at EMCHD 2024 from multiple in vivo and ex vivo models provide strong evidence of INF904’s significant anti-inflammatory properties and strong pharmacokinetic properties, further supporting our belief that INF904 may have differentiating advantages as a member of the C5aR inhibitor drug class.”

Preclinical pharmacological characterization of INF904, an oral small molecule antagonist to complement 5a receptor1 (C5aR1)Rui Liu, Zhongli Xu, Ophelia Chen, Bruce P. Burnett, Maria Habel, Renfeng Guo

Overall, this study demonstrated that INF904 is a highly selective and potent inhibitor of C5aR1 with promising pharmacokinetic (PK) properties, while also exhibiting strong efficacy potential in vivo. Both INF904 and avacopan were evaluated through a series of cell-based, ex vivo, and in vivo assays. In a hamster neutropenia model, INF904 inhibited C5a-induced neutropenia by 96.5% compared to 51.1% for the same dose of avacopan. INF904 also demonstrated a more favorable PK profile with 2- to 5-fold higher exposure than avacopan across all tested animal species. The data also indicated that INF904 is a much weaker inhibitor of CYP3A4/5, with an IC50 value of 62 µM, compared to 1.7 µM for avacopan. CYP3A4/5 enzymes play an important role in the metabolism of a variety of drugs, including glucocorticoids.

INF904, a novel oral C5a receptor 1 (C5aR1) antagonist, shows promising therapeutic effects in inflammatory disease modelsZhongli Xu, Rui Liu, Ophelia Chen, Bruce P. Burnett, Maria Habel, Renfeng Guo

Results from in vitro and in vivo inflammatory disease models indicated that INF904 acts by reducing neutrophil activation. In two in vitro whole blood disease models, INF904 effectively blocked CD11b upregulation on neutrophils in a dose-dependent manner. Further, in three hamster models used to assess INF904’s therapeutic effects after oral dosing, significant anti-inflammatory effects were noted, including reduced influx of neutrophils, significant reductions in plasma levels of CREA and BUN, and histological improvements.

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 ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period.

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, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.de	Katja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.S.: +1-339-832-0752

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