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InflaRx Announces Decision To Enter Phase III Development Of IFX‑1 In Severe COVID-19 Induced Pneumonia

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

  • 2020
  • 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

 

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,” “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 the planned continuation into a Phase III part trial in patients with severe COVID-19 pneumonia; the impact of the COVID-19 pandemic on the Company; the timing and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, 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.
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