{"id":5063,"date":"2020-04-01T11:45:08","date_gmt":"2020-04-01T09:45:08","guid":{"rendered":"https:\/\/www.bm-t.de\/v4\/2020\/10\/07\/inflarx-doses-first-patient-in-multicenter-randomized-clinical-trial-in-severe-progressed-covid-19-pneumonia-in-europe-upon-receipt-of-initial-positive-human-data-with-inflarxs-anti-c5a-techn\/"},"modified":"2020-11-05T12:21:08","modified_gmt":"2020-11-05T11:21:08","slug":"inflarx-doses-first-patient-in-multicenter-randomized-clinical-trial-in-severe-progressed-covid-19-pneumonia-in-europe-upon-receipt-of-initial-positive-human-data-with-inflarxs-anti-c5a-techn","status":"publish","type":"post","link":"https:\/\/www.bm-t.de\/en\/2020-en\/inflarx-doses-first-patient-in-multicenter-randomized-clinical-trial-in-severe-progressed-covid-19-pneumonia-in-europe-upon-receipt-of-initial-positive-human-data-with-inflarxs-anti-c5a-techn\/","title":{"rendered":"InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon Receipt of Initial Positive Human Data with InflaRx\u2019s anti-C5a Technology"},"content":{"rendered":"<div>\n<section class=\"top-padding-sm bottom-padding-sm white\">\n<ul>\n<li>InflaRx has dosed the first patient in an adap\u00adtive ran\u00addom\u00adized con\u00adtrolled clin\u00adi\u00adcal study with IFX\u20111&nbsp;in patients with severe COVID-19 pneu\u00admo\u00adnia in the Netherlands<\/li>\n<li>InflaRx received ini\u00adtial pos\u00adi\u00adtive human data from its licensee, Bei\u00adjing Defen\u00adgrei Biotech\u00adnol\u00adogy Co. Ltd. (BDB), sug\u00adgest\u00ading a poten\u00adtial role of C5a in COVID-19<\/li>\n<\/ul>\n<p>InflaRx N.V. (Nas\u00addaq: IFRX), a clin\u00adi\u00adcal-stage bio\u00adphar\u00adma\u00adceu\u00adti\u00adcal com\u00adpany devel\u00adop\u00ading anti-inflam\u00adma\u00adtory ther\u00ada\u00adpeu\u00adtics by tar\u00adget\u00ading the com\u00adple\u00adment sys\u00adtem, today announced the enroll\u00adment of the first patient into a ran\u00addom\u00adized clin\u00adi\u00adcal trial inves\u00adti\u00adgat\u00ading the safety and effi\u00adcacy of IFX\u20111, the company\u00b4s mon\u00ado\u00adclonal anti-C5a anti\u00adbody, in patients with severe COVID-19-induced pneu\u00admo\u00adnia. The com\u00adpany has received ini\u00adtial pos\u00adi\u00adtive human data from two ini\u00adtial patients suf\u00adfer\u00ading from COVID-19-induced severe pneu\u00admo\u00adnia who were treated with BDB-001, an anti-C5a anti\u00adbody pro\u00adduced by BDB from the IFX\u20111 cell line, in China. Data from the two patients are part of a larger inves\u00adti\u00adga\u00adtion on the role of com\u00adple\u00adment acti\u00adva\u00adtion in COVID-19 which have been made pub\u00adlicly avail\u00adable through a pre-print server and have not been inde\u00adpen\u00addently val\u00adi\u00addated by InflaRx. Based on the company\u00b4s exist\u00ading pre-clin\u00adi\u00adcal research on the role of C5a in viral-induced pneu\u00admo\u00adnia and the ini\u00adtial results from the BDB study, InflaRx has decided to ini\u00adti\u00adate a clin\u00adi\u00adcal devel\u00adop\u00adment pro\u00adgram with IFX\u20111&nbsp;in COVID-19 patients with severely pro\u00adgressed pneu\u00admo\u00adnia. The com\u00adpany has received reg\u00adu\u00adla\u00adtory approval to start the trial in the Nether\u00adlands and enrolled the first patient at the Ams\u00adter\u00addam Uni\u00adver\u00adsity Med\u00adical Cen\u00adters. Sub\u00adject to reg\u00adu\u00adla\u00adtory approval, the com\u00adpany plans to ini\u00adti\u00adate addi\u00adtional cen\u00adters in Ger\u00admany and poten\u00adtially other Euro\u00adpean coun\u00adtries. With regard to InflaRx\u2019s other ongo\u00ading clin\u00adi\u00adcal tri\u00adals, the com\u00adpany is mon\u00adi\u00adtor\u00ading the impact of COVID-19 on its pro\u00adgrams. The company\u2019s cur\u00adrent clin\u00adi\u00adcal trial sites remain active; how\u00adever, it is pos\u00adsi\u00adble that sites have paused or will pause screen\u00ading of new patients, and there may be other delays or con\u00adse\u00adquences as the pan\u00addemic evolves. There\u00adfore, we can\u00adnot pre\u00addict the future impact on the pro\u00adgrams or the com\u00adpany as a whole at present.<\/p><\/section>\n<h3 class=\"top-padding-sm bottom-padding-sm white\"><strong>About IFX\u20111<\/strong><\/h3>\n<section class=\"top-padding-sm bottom-padding-sm white\">IFX\u20111 is a first-in-class mon\u00ado\u00adclonal anti-human com\u00adple\u00adment fac\u00adtor C5a anti\u00adbody, which highly and effec\u00adtively blocks the bio\u00adlog\u00adi\u00adcal activ\u00adity of C5a and demon\u00adstrates high selec\u00adtiv\u00adity towards its tar\u00adget in human blood. Thus, IFX\u20111 leaves the for\u00adma\u00adtion of the mem\u00adbrane attack com\u00adplex (C5b\u20119) intact as an impor\u00adtant defense mech\u00ada\u00adnism, which is not the case for mol\u00ade\u00adcules block\u00ading the cleav\u00adage of C5. IFX\u20111 has been demon\u00adstrated to con\u00adtrol the inflam\u00adma\u00adtory response dri\u00adven tis\u00adsue and organ dam\u00adage by specif\u00adi\u00adcally block\u00ading C5a as a key \u201campli\u00adfier\u201d of this response in pre-clin\u00adi\u00adcal stud\u00adies. IFX\u20111 is believed to be the first mon\u00ado\u00adclonal anti-C5a anti\u00adbody intro\u00adduced into clin\u00adi\u00adcal devel\u00adop\u00adment. Approx\u00adi\u00admately 300 peo\u00adple have been treated with IFX\u20111&nbsp;in clin\u00adi\u00adcal tri\u00adals, and the anti\u00adbody has been shown to be well tol\u00ader\u00adated. IFX\u20111 is cur\u00adrently being devel\u00adoped for var\u00adi\u00adous inflam\u00adma\u00adtory indi\u00adca\u00adtions, includ\u00ading Hidradeni\u00adtis Sup\u00adpu\u00adra\u00adtiva, ANCA-asso\u00adci\u00adated vas\u00adculi\u00adtis and Pyo\u00adderma Gan\u00adgraeno\u00adsum.<strong>About InflaRx N.V.:<\/strong> InflaRx (Nas\u00addaq: IFRX) is a clin\u00adi\u00adcal-stage bio\u00adphar\u00adma\u00adceu\u00adti\u00adcal com\u00adpany focused on apply\u00ading its pro\u00adpri\u00adetary anti-C5a tech\u00adnol\u00adogy to dis\u00adcover and develop first-in-class, potent and spe\u00adcific inhibitors of C5a. Com\u00adple\u00adment C5a is a pow\u00ader\u00adful inflam\u00adma\u00adtory medi\u00ada\u00adtor involved in the pro\u00adgres\u00adsion of a wide vari\u00adety of autoim\u00admune and other inflam\u00adma\u00adtory dis\u00adeases. InflaRx was founded in 2007, and the group has offices and sub\u00adsidiaries in Jena and Munich, Ger\u00admany, as well as Ann Arbor, MI, USA. For fur\u00adther infor\u00adma\u00adtion please visit&nbsp;<a href=\"http:\/\/www.inflarx.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">www.inflarx.com<\/a>. On Decem\u00adber 28, 2015, InflaRx entered into a co-devel\u00adop\u00adment agree\u00adment with Bei\u00adjing Defen\u00adgrei Biotech\u00adnol\u00adogy Co. Ltd., or BDB, for the use of the IFX\u20111 tech\u00adnol\u00adogy and cell line in BDB\u2019s devel\u00adop\u00adment of drug can\u00addi\u00addates for sale in China. Pur\u00adsuant to the agree\u00adment, InflaRx granted BDB an exclu\u00adsive, non-trans\u00adfer\u00adable license to use the IFX\u20111 cell line and related intel\u00adlec\u00adtual prop\u00aderty solely to develop and com\u00admer\u00adcial\u00adize BDB\u2019s drug can\u00addi\u00addates, includ\u00ading BDB-001, in China.&nbsp; Pur\u00adsuant to the agree\u00adment, InflaRx is enti\u00adtled to receive roy\u00adal\u00adties on net sales of BDB\u2019s prod\u00aducts con\u00adtain\u00ading BDB-001 and reserves the right to com\u00admer\u00adcial\u00adize prod\u00aducts con\u00adtain\u00ading BDB-001 out\u00adside of&nbsp;China.<\/section>\n<section class=\"top-padding-sm bottom-padding-sm white\"><strong>Con\u00adtacts:<\/strong><\/section>\n<section class=\"top-padding-sm bottom-padding-sm\"><\/section>\n<div class=\"complextable\">\n<div class=\"complextablerow\">\n<div class=\"complextablecolumn\">\n<div><strong>InflaRx N.V.<\/strong> Jor\u00addan Zwick \u2013 Global Head of Busi\u00adness Devel\u00adop\u00adment &amp; Cor\u00adpo\u00adrate Strat\u00adegy <a href=\"inflarx@mc-services.eu\" target=\"_blank\" rel=\"noopener noreferrer\">jordan.zwick[at]inflarx.de<\/a> Tel:&nbsp;+1 917\u2212338\u22126523<\/div>\n<\/div>\n<div class=\"complextablecolumn\">\n<div>&nbsp; <strong>Investor \/ Media Rela\u00adtions Sup\u00adport<\/strong> <strong>MC Ser\u00advices AG<\/strong> Katja Arnold, Lau\u00adrie Doyle, Andreas Jungfer <a>inflarx[at]mc-services.eu<\/a> Europe: +49 89\u2013210 2280 US: +1\u2013339\u2013832\u20110752<\/div>\n<div>&nbsp;<\/div>\n<\/div>\n<\/div>\n<div class=\"complextablerowspaceafter\">&nbsp;<\/div>\n<\/div>\n<section class=\"top-padding-sm bottom-padding-sm white\">FORWARD-LOOKING STATEMENTS<em>This press release con\u00adtains for\u00adward-look\u00ading state\u00adments. All state\u00adments other than state\u00adments of his\u00adtor\u00adi\u00adcal fact are for\u00adward-look\u00ading state\u00adments, which are often indi\u00adcated by terms such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cexpect,\u201d \u201cplan,\u201d \u201cantic\u00adi\u00adpate,\u201d \u201ccould,\u201d \u201cintend,\u201d \u201ctar\u00adget,\u201d \u201cproject,\u201d \u201cesti\u00admate,\u201d \u201cbelieve,\u201d \u201cesti\u00admate,\u201d \u201cpre\u00addict,\u201d \u201cpoten\u00adtial\u201d or \u201ccon\u00adtinue\u201d and sim\u00adi\u00adlar expres\u00adsions. For\u00adward-look\u00ading state\u00adments appear in a num\u00adber of places through\u00adout this release and may include state\u00adments regard\u00ading our inten\u00adtions, beliefs, pro\u00adjec\u00adtions, out\u00adlook, analy\u00adses and cur\u00adrent expec\u00adta\u00adtions con\u00adcern\u00ading, among other things, our ongo\u00ading and planned pre\u00adclin\u00adi\u00adcal devel\u00adop\u00adment and clin\u00adi\u00adcal tri\u00adals, includ\u00ading with respect to IFX\u20111 for the treat\u00adment of patients with severe COVID-19 pneu\u00admo\u00adnia, the impact of the COVID-19 pan\u00addemic on the com\u00adpany, the tim\u00ading of and our abil\u00adity to com\u00admence and con\u00adduct clin\u00adi\u00adcal tri\u00adals, make reg\u00adu\u00adla\u00adtory fil\u00adings and obtain and main\u00adtain reg\u00adu\u00adla\u00adtory approvals for our prod\u00aduct can\u00addi\u00addates, our intel\u00adlec\u00adtual prop\u00aderty posi\u00adtion, our abil\u00adity to develop com\u00admer\u00adcial func\u00adtions, expec\u00adta\u00adtions regard\u00ading clin\u00adi\u00adcal trial data, our results of oper\u00ada\u00adtions, cash needs, finan\u00adcial con\u00addi\u00adtion, liq\u00aduid\u00adity, prospects, future trans\u00adac\u00adtions, growth and strate\u00adgies, the indus\u00adtry in which we oper\u00adate, the trends that may affect the indus\u00adtry or us and the risks uncer\u00adtain\u00adties and other fac\u00adtors described under the head\u00ading \u201cRisk Fac\u00adtors\u201d in InflaRx\u2019s peri\u00adodic fil\u00adings with the Secu\u00adri\u00adties and Exchange Com\u00admis\u00adsion. These state\u00adments speak only as of the date of this press release and involve known and unknown risks, uncer\u00adtain\u00adties and other impor\u00adtant fac\u00adtors that may cause our actual results, per\u00adfor\u00admance or achieve\u00adments to be mate\u00adri\u00adally dif\u00adfer\u00adent from any future results, per\u00adfor\u00admance or achieve\u00adments expressed or implied by the for\u00adward-look\u00ading state\u00adments. Given these risks, uncer\u00adtain\u00adties and other fac\u00adtors, you should not place undue reliance on these for\u00adward-look\u00ading state\u00adments, and we assume no oblig\u00ada\u00adtion to update these for\u00adward-look\u00ading state\u00adments, even if new infor\u00adma\u00adtion becomes avail\u00adable in the future, except as required by&nbsp;law.<\/em><\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>InflaRx has dosed the first patient in an adap\u00adtive ran\u00addom\u00adized con\u00adtrolled clin\u00adi\u00adcal study with IFX\u20111&nbsp;in patients with severe COVID-19 pneu\u00admo\u00adnia in the Nether\u00adlands InflaRx received ini\u00adtial pos\u00adi\u00adtive human data from its licensee, Bei\u00adjing Defen\u00adgrei Biotech\u00adnol\u00adogy Co. Ltd. (BDB), sug\u00adgest\u00ading a poten\u00adtial role of C5a in COVID-19 InflaRx N.V. (Nas\u00addaq: IFRX), a clin\u00adi\u00ad\u00adcal-stage bio\u00adphar\u00adma\u00adceu\u00adti\u00adcal com\u00adpany developing&nbsp;[\u2026]<\/p>\n","protected":false},"author":2,"featured_media":8884,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wp_typography_post_enhancements_disabled":false,"footnotes":""},"categories":[149],"tags":[151,155,179],"class_list":["post-5063","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-2020-en","tag-antibodies","tag-corona-en","tag-covid-19-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/5063","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/comments?post=5063"}],"version-history":[{"count":0,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/5063\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media\/8884"}],"wp:attachment":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media?parent=5063"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/categories?post=5063"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/tags?post=5063"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}