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InflaRx announces positive top-line results from phase II‑a of the SCIENS trial investigating IFX‑1, a first-in-class, anti-complement C5a antibody

  • 2016

Jena, Ger­many – InflaRx, a bio­phar­ma­ceu­ti­cal com­pany devel­op­ing new ther­a­peu­tics in the ter­mi­nal com­ple­ment space, announced pos­i­tive result­sto­day from its SCIENS phase II‑a clin­i­cal trial of IFX‑1, a first-in-class mon­o­clonal anti-C5a anti­body. The trial reached all pri­mary end­points and demon­strated safety, tol­er­a­bil­ity and bio­log­i­cal proof of con­cept of IFX‑1 in patients suf­fer­ing from early sep­tic organ dysfunction.

IFX‑1 is highly sta­tis­ti­cally-sig­nif­i­cant in reduc­ing and effec­tively block­ing C5a in a dose-depen­dent man­ner. In addi­tion, the data showed pos­i­tive trends in sev­eral other clin­i­cally rel­e­vant effi­cacy end­points, such as organ dys­func­tion score (SOFA score), need for ven­ti­la­tor sup­port and length of stay on the ICU. IFX‑1 is the first mon­o­clonal anti-C5a anti­body intro­duced into clin­i­cal devel­op­ment, which has now suc­cess­fully com­pleted a clin­i­cal phase II study in patients.

Prof. Niels Riede­mann, co-founder and CEO of InflaRx com­mented, “After 15 years of focused research and devel­op­ment around C5a, one of the most promis­ing tar­gets in inflam­ma­tion, we are excited that we can now demon­strate the power of our tech­nol­ogy in patients. We devel­oped IFX‑1 to become a game-changer in the inten­sive care field and these new results bring us a big step closer to this goal.”

The SCIENS trial enrolled 72 patients suf­fer­ing from early sep­tic organ dys­func­tion in a placebo–controlled, dou­ble-blinded dose esca­la­tion design and was con­ducted within the Sep­Net study trial group in 15 Ger­man ICUs (inten­sive care units). The study inves­ti­gated the pharmacokinetics/pharmacodynamics (PK/PD), safety and tol­er­a­bil­ity of IFX‑1 as well as var­i­ous exploratory sec­ondary clin­i­cal end­points. Fur­ther­more, it rep­re­sented a first-in-class clin­i­cal trial in the infec­tious acute care space, as it enrolled focus-selected patients suf­fer­ing from early organ dys­func­tion within only 3.5 hours of screen­ing to eval­u­ate the ben­e­fits of an early Intervention.

We designed this study to gain in-depth knowl­edge about IFX‑1 con­sump­tion and com­ple­ment acti­va­tion in this patient pop­u­la­tion. We will use the upcom­ing weeks to care­fully ana­lyze all data in order to tai­lor the planned phase II‑b trial in this vital area of unmet med­ical need,” noted Dr. Oth­mar Zenker, Head of Clin­i­cal R&D at InflaRx.

InflaRx has taken a highly inno­v­a­tive clin­i­cal trial approach in inves­ti­gat­ing this very promis­ing anti­body to tackle one of the most life-threat­en­ing events within the entire acute care field: inflam­ma­tion-induced organ fail­ure. Based on these encour­ag­ing results, we are opti­mistic that the fur­ther devel­op­ment of IFX‑1 could be of sig­nif­i­cant ben­e­fit to patients with this dev­as­tat­ing con­di­tion and their doc­tors, where thus far no ther­apy is avail­able,” con­cluded Prof. Michael Bauer, who serves as study PI, Chair­man of Anes­the­si­ol­ogy and Inten­sive Care Med­i­cine and Chair­man of the Cen­ter for Sep­sis Con­trol and Care at Jena Uni­ver­sity Hospital.

About sep­tic organ dys­func­tion and com­ple­ment C5a:

In seri­ous infec­tions, the body’s immune sys­tem acti­vates inflam­ma­tory response mech­a­nisms which have been described as the cause of self-induced tis­sue and organ dam­age, such as oxy­gen rad­i­cal for­ma­tion and enzyme and cytokine release by acti­vated blood cells. This dam­age quickly leads to organ dys­func­tion and, ulti­mately, organ fail­ure, which is the lead cause of death of patients in most ICUs world­wide. Sim­i­lar mech­a­nisms have been described in other infec­tious dis­eases, such as malaria and dengue fever, as well as in non-infec­tious inflam­ma­tion, such as large oper­a­tions, burns or trauma. Sev­eral inter­na­tional sci­en­tific groups and the founders of InflaRx have iden­ti­fied C5a as a key “ampli­fy­ing fac­tor” of most acute inflam­ma­tory responses. In exper­i­men­tal mod­els, early block­ade of C5a resulted in the preser­va­tion of organ func­tion and improved sur­vival by down-reg­u­la­tion of the immune cell-induced tis­sue dam­age and var­i­ous other inflam­ma­tory responses.

About IFX‑1:

IFX‑1 is a first-in-class, mon­o­clonal, anti-human com­ple­ment C5a anti­body which demon­strates a com­plete bio­log­i­cal block­ing activ­ity and selec­tiv­ity towards its tar­get, C5a, leav­ing the impor­tant defense mech­a­nism of C5b‑9 for­ma­tion intact. IFX‑1 is thought to con­trol the inflam­ma­tory response-dri­ven tis­sue and organ dam­age by specif­i­cally block­ing C5a as a key “ampli­fier” of this response. IFX‑1 is cur­rently in clin­i­cal phase II devel­op­ment for sev­eral dif­fer­ent acute and life-threat­en­ing inflam­ma­tory indications.

About InflaRx:

InflaRx is a bio­phar­ma­ceu­ti­cal com­pany focus­ing on the devel­op­ment of new ther­a­peu­tics to con­trol the body’s inflam­ma­tory response, based on its pro­pri­etary tech­nol­ogy. InflaRx has devel­oped a pipeline of first-in-class anti­bod­ies directed against the ter­mi­nal com­ple­ment com­po­nent C5a. While IFX‑1 focuses on the acute care space, its prod­uct can­di­dates, IFX‑2 and IFX‑3, are being devel­oped in chronic inflam­ma­tory dis­ease indi­ca­tions. InflaRx was founded in 2007 and is head­quar­tered in Jena, Ger­many, with long-stand­ing research col­lab­o­ra­tions in the US and China. The team con­sists of renowned experts in com­ple­ment research and clin­i­cal acute care. InflaRx is pri­vately owned and financed by bm‑t beteili­gungs­man­age­ment thürin­gen Gmbh, KfW Bank­ing Group and var­i­ous inter­na­tional fam­ily offices.

Contacts:

InflaRx GmbH
Niels C. Riede­mann — CEO
Email:
Tel.: +49–3641-508180

www.inflarx.de

MC Ser­vices AG
Katja Arnold / Dr. Cora Kaiser
Email: /
Tel.: +49–89-210 2280

The Trout Group
Jen­nifer Por­celli / Thomas Hoffmann
Email: /
Tel.: +1 646 378 2900

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