July, 31 2020 InflaRx Announces Decision to Enter Phase III Development of IFX‑1 in Severe COVID-19 Induced Pneumonia

  • 50% lower all-cause mor­tal­ity rate and other effi­cacy trends were shown with IFX‑1 in ini­tial data from the ran­dom­ized exploratory Phase II part of the Phase II/III trial
  • Sub­ject to reg­u­la­tory approval, a ran­dom­ized, dou­ble-blinded, placebo-con­trolled, multi­na­tional Phase III part of the trial will be initiated
  • Pri­mary end­point of the planned Phase III part to be 28-day all-cause mortality
InflaRx (Nas­daq: IFRX), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pany devel­op­ing anti-inflam­ma­tory ther­a­peu­tics by tar­get­ing the com­ple­ment sys­tem, announced today that the Com­pany has decided to con­tinue devel­op­ment with IFX‑1 in severe COVID-19 induced pneu­mo­nia.  The Com­pany plans to ini­ti­ate a dou­ble-blinded, ran­dom­ized, placebo-con­trolled Phase III trial that will be ade­quately pow­ered for sta­tis­ti­cal analy­ses. In the Phase III part of the study, sub­ject to reg­u­la­tory approval, the Com­pany plans to enroll approx­i­mately 360 early intu­bated, crit­i­cally ill patients with COVID-19 induced pneu­mo­nia. InflaRx plans to con­duct the study at sites in the US, Europe, South Amer­ica and poten­tially other regions. An interim analy­sis is cur­rently planned after enroll­ment of 180 patients, with the poten­tial for an early stop for effi­cacy or futil­ity. In addi­tion to the pri­mary end­point of 28-day all-cause mor­tal­ity, other planned key end­points include assess­ments of organ sup­port and assess­ment of dis­ease improve­ment on the ordi­nal scale. Dr. Korinna Pilz, Global Head of Clin­i­cal R&D at InflaRx, noted: “Data from the ini­tial exploratory Phase II part of the study in patients with severe COVID-19 induced pneu­mo­nia sug­gested a pos­i­tive impact of IFX‑1 treat­ment on the all-cause mor­tal­ity rate and other end­points. Based on these encour­ag­ing results, we are excited to ini­ti­ate the Phase III part of the trial, which we antic­i­pate start­ing in the com­ing months.” The Phase II part of the study eval­u­ated IFX‑1 treat­ment plus best sup­port­ive care com­pared to best sup­port­ive care alone for up to 28 days. The Phase II part was ran­dom­ized and enrolled a total of 30 patients. The 28-day all-cause mor­tal­ity rate was 13% (n = 2 out of 15) in the IFX‑1 treat­ment arm com­pared to 27% (n = 4 out of 15) in the best sup­port­ive care arm. All deaths in the best sup­port­ive care arm occurred in COVID-19 induced multi-organ fail­ure. In the IFX‑1 treat­ment arm, one patient died after an acute ven­ti­la­tor tube com­pli­ca­tion (leak­age) lead­ing to hypoxia and one patient who met an exclu­sion cri­te­rion with a his­tory of severe chronic obstruc­tive pul­monary dis­ease, which was not known at time point of enroll­ment, died of pul­monary fail­ure. In the IFX‑1 treat­ment arm fewer patients expe­ri­enced renal impair­ment assessed by esti­mated glomeru­lar fil­tra­tion rates and more patients showed rever­sal of blood lym­pho­cy­tope­nia and a greater low­er­ing of lac­tate dehy­dro­ge­nase con­cen­tra­tions as a sign of reduc­tion in tis­sue dam­age. A tem­po­rary, but sta­tis­ti­cally sig­nif­i­cant increase of D‑dimer lev­els in the first days fol­low­ing IFX‑1 admin­is­tra­tion was noted, as a poten­tial sig­nal for induc­tion of blood clot lysis. No sta­tis­ti­cally sig­nif­i­cant group dif­fer­ences on the cho­sen pri­mary end­point of rel­a­tive change (%) from base­line to day 5 in oxy­gena­tion index (defined as PaO2/FiO2 ratio) were detected. The Phase II results have been sub­mit­ted for pub­li­ca­tion to a peer-reviewed med­ical jour­nal along with a preprint Server.

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 indi­ca­tions, includ­ing Hidradeni­tis Sup­pu­ra­tiva, ANCA-asso­ci­ated vas­culi­tis, Pyo­derma Gan­graeno­sum and COVID-19 induced pneu­mo­nia. 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.
Con­tacts: 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