{"id":5033,"date":"2020-07-31T10:10:37","date_gmt":"2020-07-31T08:10:37","guid":{"rendered":"https:\/\/www.bm-t.de\/v4\/2020\/10\/07\/inflarx-announces-decision-to-enter-phase-iii-development-of-ifx%e2%80%911-in-severe-covid-19-induced-pneumonia\/"},"modified":"2020-11-05T12:05:25","modified_gmt":"2020-11-05T11:05:25","slug":"inflarx-announces-decision-to-enter-phase-iii-development-of-ifx%e2%80%911-in-severe-covid-19-induced-pneumonia","status":"publish","type":"post","link":"https:\/\/www.bm-t.de\/en\/2020-en\/inflarx-announces-decision-to-enter-phase-iii-development-of-ifx%e2%80%911-in-severe-covid-19-induced-pneumonia\/","title":{"rendered":"InflaRx Announces Decision to Enter Phase III Development of IFX\u20111&nbsp;in Severe COVID-19 Induced Pneumonia"},"content":{"rendered":"<div>\n<ul>\n<li>50% lower all-cause mor\u00adtal\u00adity rate and other effi\u00adcacy trends were shown with IFX\u20111&nbsp;in ini\u00adtial data from the ran\u00addom\u00adized exploratory Phase II part of the Phase II\/III trial<\/li>\n<li>Sub\u00adject to reg\u00adu\u00adla\u00adtory approval, a ran\u00addom\u00adized, dou\u00adble-blinded, placebo-con\u00adtrolled, multi\u00adna\u00adtional Phase III part of the trial will be initiated<\/li>\n<li>Pri\u00admary end\u00adpoint of the planned Phase III part to be 28-day all-cause mortality<\/li>\n<\/ul>\n<div>InflaRx (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, announced today that the Com\u00adpany has decided to con\u00adtinue devel\u00adop\u00adment with IFX\u20111&nbsp;in severe COVID-19 induced pneu\u00admo\u00adnia.&nbsp; The Com\u00adpany plans to ini\u00adti\u00adate a dou\u00adble-blinded, ran\u00addom\u00adized, placebo-con\u00adtrolled Phase III trial that will be ade\u00adquately pow\u00adered for sta\u00adtis\u00adti\u00adcal analy\u00adses. In the Phase III part of the study, sub\u00adject to reg\u00adu\u00adla\u00adtory approval, the Com\u00adpany plans to enroll approx\u00adi\u00admately 360 early intu\u00adbated, crit\u00adi\u00adcally ill patients with COVID-19 induced pneu\u00admo\u00adnia. InflaRx plans to con\u00adduct the study at sites in the US, Europe, South Amer\u00adica and poten\u00adtially other regions. An interim analy\u00adsis is cur\u00adrently planned after enroll\u00adment of 180 patients, with the poten\u00adtial for an early stop for effi\u00adcacy or futil\u00adity. In addi\u00adtion to the pri\u00admary end\u00adpoint of 28-day all-cause mor\u00adtal\u00adity, other planned key end\u00adpoints include assess\u00adments of organ sup\u00adport and assess\u00adment of dis\u00adease improve\u00adment on the ordi\u00adnal scale. Dr. Korinna Pilz, Global Head of Clin\u00adi\u00adcal R&amp;D at InflaRx, noted: \u201cData from the ini\u00adtial exploratory Phase II part of the study in patients with severe COVID-19 induced pneu\u00admo\u00adnia sug\u00adgested a pos\u00adi\u00adtive impact of IFX\u20111 treat\u00adment on the all-cause mor\u00adtal\u00adity rate and other end\u00adpoints. Based on these encour\u00adag\u00ading results, we are excited to ini\u00adti\u00adate the Phase III part of the trial, which we antic\u00adi\u00adpate start\u00ading in the com\u00ading months.\u201d The Phase II part of the study eval\u00adu\u00adated IFX\u20111 treat\u00adment plus best sup\u00adport\u00adive care com\u00adpared to best sup\u00adport\u00adive care alone for up to 28&nbsp;days. The Phase II part was ran\u00addom\u00adized and enrolled a total of 30 patients. The 28-day all-cause mor\u00adtal\u00adity rate was 13% (n = 2 out of 15) in the IFX\u20111 treat\u00adment arm com\u00adpared to 27% (n = 4 out of 15) in the best sup\u00adport\u00adive care arm. All deaths in the best sup\u00adport\u00adive care arm occurred in COVID-19 induced multi-organ fail\u00adure. In the IFX\u20111 treat\u00adment arm, one patient died after an acute ven\u00adti\u00adla\u00adtor tube com\u00adpli\u00adca\u00adtion (leak\u00adage) lead\u00ading to hypoxia and one patient who met an exclu\u00adsion cri\u00adte\u00adrion with a his\u00adtory of severe chronic obstruc\u00adtive pul\u00admonary dis\u00adease, which was not known at time point of enroll\u00adment, died of pul\u00admonary fail\u00adure. In the IFX\u20111 treat\u00adment arm fewer patients expe\u00adri\u00adenced renal impair\u00adment assessed by esti\u00admated glomeru\u00adlar fil\u00adtra\u00adtion rates and more patients showed rever\u00adsal of blood lym\u00adpho\u00adcy\u00adtope\u00adnia and a greater low\u00ader\u00ading of lac\u00adtate dehy\u00addro\u00adge\u00adnase con\u00adcen\u00adtra\u00adtions as a sign of reduc\u00adtion in tis\u00adsue dam\u00adage. A tem\u00adpo\u00adrary, but sta\u00adtis\u00adti\u00adcally sig\u00adnif\u00adi\u00adcant increase of D\u2011dimer lev\u00adels in the first days fol\u00adlow\u00ading IFX\u20111 admin\u00adis\u00adtra\u00adtion was noted, as a poten\u00adtial sig\u00adnal for induc\u00adtion of blood clot lysis. No sta\u00adtis\u00adti\u00adcally sig\u00adnif\u00adi\u00adcant group dif\u00adfer\u00adences on the cho\u00adsen pri\u00admary end\u00adpoint of rel\u00ada\u00adtive change (%) from base\u00adline to day 5&nbsp;in oxy\u00adgena\u00adtion index (defined as PaO2\/FiO2 ratio) were detected. The Phase II results have been sub\u00admit\u00adted for pub\u00adli\u00adca\u00adtion to a peer-reviewed med\u00adical jour\u00adnal along with a preprint Server.<\/div>\n<h3><strong>About IFX\u20111<\/strong><\/h3>\n<div>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 indi\u00adca\u00adtions, includ\u00ading Hidradeni\u00adtis Sup\u00adpu\u00adra\u00adtiva, ANCA-asso\u00adci\u00adated vas\u00adculi\u00adtis, Pyo\u00adderma Gan\u00adgraeno\u00adsum and COVID-19 induced pneu\u00admo\u00adnia. <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>.\n<div><b><strong>Con\u00adtacts:<\/strong><\/b> <b><strong>InflaRx N.V.<\/strong><\/b> Jor\u00addan Zwick \u2013 Global Head of Busi\u00adness Devel\u00adop\u00adment &amp; Cor\u00adpo\u00adrate Strat\u00adegy jordan.zwick[at]inflarx.de Tel:&nbsp;+1 917\u2212338\u22126523 <b><strong>Investor \/ Media Rela\u00adtions Sup\u00adport<\/strong><\/b> <b><strong>MC Ser\u00advices AG<\/strong><\/b> Katja Arnold, Lau\u00adrie Doyle, Andreas Jungfer inflarx[at]mc-services.eu Europe: +49 89\u2013210 2280 US: +1\u2013339\u2013832\u20110752<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The bm|t Investee part\u00adner InflaRx plans to con\u00adtinue the devel\u00adop\u00adment through a dou\u00adble-blind, ran\u00addomised, placebo-con\u00adtrolled Phase III&nbsp;study.<\/p>\n","protected":false},"author":2,"featured_media":4176,"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-5033","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\/5033","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=5033"}],"version-history":[{"count":0,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/5033\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media\/4176"}],"wp:attachment":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media?parent=5033"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/categories?post=5033"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/tags?post=5033"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}