April, 1 2020 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’s anti-C5a Technology

  • InflaRx has dosed the first patient in an adap­tive ran­dom­ized con­trolled clin­i­cal study with IFX‑1 in patients with severe COVID-19 pneu­mo­nia in the Netherlands
  • InflaRx received ini­tial pos­i­tive human data from its licensee, Bei­jing Defen­grei Biotech­nol­ogy Co. Ltd. (BDB), sug­gest­ing a poten­tial role of C5a in COVID-19

InflaRx N.V. (Nas­daq: IFRX), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pany devel­op­ing anti-inflam­ma­tory ther­a­peu­tics by tar­get­ing the com­ple­ment sys­tem, today announced the enroll­ment of the first patient into a ran­dom­ized clin­i­cal trial inves­ti­gat­ing the safety and effi­cacy of IFX‑1, the company´s mon­o­clonal anti-C5a anti­body, in patients with severe COVID-19-induced pneu­mo­nia. The com­pany has received ini­tial pos­i­tive human data from two ini­tial patients suf­fer­ing from COVID-19-induced severe pneu­mo­nia who were treated with BDB-001, an anti-C5a anti­body pro­duced by BDB from the IFX‑1 cell line, in China. Data from the two patients are part of a larger inves­ti­ga­tion on the role of com­ple­ment acti­va­tion in COVID-19 which have been made pub­licly avail­able through a pre-print server and have not been inde­pen­dently val­i­dated by InflaRx. Based on the company´s exist­ing pre-clin­i­cal research on the role of C5a in viral-induced pneu­mo­nia and the ini­tial results from the BDB study, InflaRx has decided to ini­ti­ate a clin­i­cal devel­op­ment pro­gram with IFX‑1 in COVID-19 patients with severely pro­gressed pneu­mo­nia. The com­pany has received reg­u­la­tory approval to start the trial in the Nether­lands and enrolled the first patient at the Ams­ter­dam Uni­ver­sity Med­ical Cen­ters. Sub­ject to reg­u­la­tory approval, the com­pany plans to ini­ti­ate addi­tional cen­ters in Ger­many and poten­tially other Euro­pean coun­tries. With regard to InflaRx’s other ongo­ing clin­i­cal tri­als, the com­pany is mon­i­tor­ing the impact of COVID-19 on its pro­grams. The company’s cur­rent clin­i­cal trial sites remain active; how­ever, it is pos­si­ble that sites have paused or will pause screen­ing of new patients, and there may be other delays or con­se­quences as the pan­demic evolves. There­fore, we can­not pre­dict the future impact on the pro­grams or the com­pany as a whole at present.

About IFX‑1

IFX‑1 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, IFX‑1 leaves the for­ma­tion of the mem­brane attack com­plex (C5b‑9) intact as an impor­tant defense mech­a­nism, which is not the case for mol­e­cules block­ing the cleav­age of C5. IFX‑1 has been demon­strated to con­trol the inflam­ma­tory response dri­ven tis­sue and organ dam­age by specif­i­cally block­ing C5a as a key “ampli­fier” of this response in pre-clin­i­cal stud­ies. IFX‑1 is believed to be the first mon­o­clonal anti-C5a anti­body intro­duced into clin­i­cal devel­op­ment. Approx­i­mately 300 peo­ple have been treated with IFX‑1 in clin­i­cal tri­als, and the anti­body has been shown to be well tol­er­ated. IFX‑1 is cur­rently being devel­oped for var­i­ous inflam­ma­tory indi­ca­tions, includ­ing Hidradeni­tis Sup­pu­ra­tiva, ANCA-asso­ci­ated vas­culi­tis and Pyo­derma Gan­graeno­sum.About InflaRx N.V.: InflaRx (Nas­daq: IFRX) is a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pany focused on apply­ing its pro­pri­etary anti-C5a tech­nol­ogy to dis­cover and develop first-in-class, potent and spe­cific inhibitors of C5a. Com­ple­ment C5a is a pow­er­ful inflam­ma­tory medi­a­tor involved in the pro­gres­sion of a wide vari­ety of autoim­mune and other inflam­ma­tory dis­eases. 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. On Decem­ber 28, 2015, InflaRx entered into a co-devel­op­ment agree­ment with Bei­jing Defen­grei Biotech­nol­ogy Co. Ltd., or BDB, for the use of the IFX‑1 tech­nol­ogy and cell line in BDB’s devel­op­ment of drug can­di­dates for sale in China. Pur­suant to the agree­ment, InflaRx granted BDB an exclu­sive, non-trans­fer­able license to use the IFX‑1 cell line and related intel­lec­tual prop­erty solely to develop and com­mer­cial­ize BDB’s drug can­di­dates, includ­ing BDB-001, in China.  Pur­suant to the agree­ment, InflaRx is enti­tled to receive roy­al­ties on net sales of BDB’s prod­ucts con­tain­ing BDB-001 and reserves the right to com­mer­cial­ize prod­ucts con­tain­ing BDB-001 out­side of China.
InflaRx N.V. Jor­dan Zwick – Global Head of Busi­ness Devel­op­ment & Cor­po­rate Strat­egy jordan.zwick[at]inflarx.de Tel: +1 917−338−6523
  Investor / Media Rela­tions Sup­port MC Ser­vices AG Katja Arnold, Lau­rie Doyle, Andreas Jungfer inflarx[at]mc-services.eu Europe: +49 89–210 2280 US: +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,” “esti­mate,” “pre­dict,” “poten­tial” or “con­tinue” and sim­i­lar expres­sions. 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 ongo­ing and planned pre­clin­i­cal devel­op­ment and clin­i­cal tri­als, includ­ing with respect to IFX‑1 for the treat­ment of patients with severe COVID-19 pneu­mo­nia, the impact of the COVID-19 pan­demic on the com­pany, the tim­ing of and our abil­ity to com­mence and con­duct clin­i­cal tri­als, make reg­u­la­tory fil­ings and obtain and main­tain reg­u­la­tory approvals for our prod­uct can­di­dates, our intel­lec­tual prop­erty posi­tion, our abil­ity to develop com­mer­cial func­tions, expec­ta­tions regard­ing clin­i­cal trial data, our results of oper­a­tions, cash needs, finan­cial con­di­tion, liq­uid­ity, prospects, future trans­ac­tions, growth and strate­gies, the indus­try in which we oper­ate, the trends that may affect the indus­try or us and the risks uncer­tain­ties and other fac­tors described under the head­ing “Risk Fac­tors” in InflaRx’s peri­odic fil­ings with the 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.