C5AR1 x C5a

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 45.2%, 25.1% and 31.6%, respectively. InflaRx believes this analysis suggests meaningful clinical benefit for vilobelimab in HS. Further, it supports utilizing a modified version of the HiSCR that measures drug activity against all three lesion types with an emphasis on the reduction of dT, a critical manifestation of the disease that greatly impacts patients’ quality of life. 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 AGJan Medina, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.deKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTSThis 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 heading “Risk Factors” and “Cautionary statement regarding forward looking statements” in our periodic filings with the U.S. Securities and Exchange Commission. 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.

JENA, Germany, Sept. 03, 2024 (GLOBE NEWSWIRE) -- 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 AGJan Medina, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.deKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTSThis 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 heading “Risk Factors” and “Cautionary statement regarding forward looking statements” in our periodic filings with the U.S. Securities and Exchange Commission. 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.

JENA, Germany, Aug. 27, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will participate in two investor conferences in September 2024. Details are as follows: H.C. Wainwright 26th Annual Global Investment ConferenceSeptember 9-11, 2024 in New York, NY InflaRx’s on-demand virtual presentation for the conference will be available beginning on September 9th. InflaRx will also participate in one-on-one investor meetings in New York City on September 10th. 2024 Cantor Global Healthcare ConferenceSeptember 17-19, 2024 in New York, NY InflaRx will conduct a fireside chat at the conference on September 18th at 9:45 am ET and will participate in one-on-one-investor meetings on the same day. A link to register for the fireside chat live stream and its replay is available here. About InflaRxInflaRx (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 AGJan Medina, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.deKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.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, current expectations and the risks, uncertainties and other factors described under the heading “Risk Factors” and “Cautionary statement regarding forward looking statements” in our periodic filings with the U.S. Securities and Exchange Commission. 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.