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InflaRx Reports Topline Phase IIa Clinical Results of IFX‑1 for the Treatment of Hidradenitis Suppurativa

  • 2017

IFX‑1 demon­strates dis­ease mod­i­fy­ing activity

Jena, Ger­many, — InflaRx, the bio­phar­ma­ceu­ti­cal com­pany devel­op­ing new ther­a­peu­tics in the ter­mi­nal com­ple­ment space, announced today pos­i­tive topline data from an exploratory Phase IIa clin­i­cal trial with lead com­pound IFX‑1, a first-in-class anti-human com­ple­ment fac­tor C5a mon­o­clonal anti­body, in patients suf­fer­ing from mod­er­ate to severe Hidradeni­tis Sup­pu­ra­tiva (HS), a painful, chronic and debil­i­tat­ing inflam­ma­tory skin disease.

This open label, sin­gle cen­ter study recruited twelve patients with mod­er­ate to severe HS, who were not eli­gi­ble for or failed to respond to pre­vi­ous ther­apy with bio­log­i­cals. Patients were treated with weekly intra­venous injec­tions of IFX‑1 for eight con­sec­u­tive weeks and were then fol­lowed up for an addi­tional period of twelve weeks. The study was con­ducted to pri­mar­ily assess the safety and tol­er­a­bil­ity of IFX‑1 in HS patients. Ini­tial effi­cacy of treat­ment was assessed through response rate, as mea­sured by the val­i­dated and clin­i­cally rel­e­vant Hidradeni­tis Sup­pu­ra­tiva Clin­i­cal Response (HiSCR) score. This score is defined as a reduc­tion of 50% or higher in inflam­ma­tory lesion count (abscesses and inflam­ma­tory nod­ules) and no increase in abscesses or drain­ing fis­tu­las when com­pared with base­line. The sever­ity and extent of HS was assessed using the Hur­ley Stages scor­ing sys­tem, which describes three dis­tinct clin­i­cal stages of HS.

In the study, all twelve patients were cat­e­go­rized as Hur­ley Stage III and there­fore most pro­gressed dis­eased patients, demon­strat­ing a mean dura­tion of HS of 19.9 years. Nine out of the twelve patients had pre­vi­ously failed to respond to an anti-TNF-alpha anti­body, the only approved bio­log­i­cal treat­ment in this indi­ca­tion. The mean com­bined num­ber of lesions (abscesses and inflam­ma­tory nod­ules) and drain­ing fis­tu­las at base­line was 6.4. and 11.2, respec­tively. Assess­ment of the HiSCR score demon­strated a response rate of 75% (nine out of twelve patients) at the end of the treat­ment period and 83% (ten out of twelve) at the end of the twelve week fol­low up period. The weekly intra­venous infu­sions of IFX‑1 were well tol­er­ated. No drug-related adverse events were detected and no infu­sion-related, aller­gic or ana­phy­lac­tic reac­tions were observed.

In addi­tion, pos­i­tive trends of clin­i­cal improve­ment were also detected with other rel­e­vant para­me­ters, includ­ing the der­ma­tol­ogy life-qual­ity index, a patient-reported out­come measure.

«These pos­i­tive results in some of the sick­est and most debil­i­tated of our HS patients are very encour­ag­ing and excit­ing for both, the study team and myself. C5a block­ade with IFX‑1 offers an entirely new mode of action to treat this dis­ease in which the ter­mi­nal com­ple­ment sys­tem is highly acti­vated,» com­mented Pro­fes­sor Gia­marel­los-Bour­boulis of the National and Kapodis­trian Uni­ver­sity of Athens, prin­ci­ple inves­ti­ga­tor of the study. «IFX‑1 may offer a new treat­ment option for patients suf­fer­ing from this ter­ri­ble dis­ease and the results cer­tainly war­rant fur­ther clin­i­cal tri­als,» he added.

«Our results show improve­ment in a patient pop­u­la­tion that is gen­er­ally rec­og­nized as the most dif­fi­cult-to-treat. For this rea­son, this trial pro­vides excit­ing evi­dence of a new ther­a­peu­tic approach,» said Oth­mar Zenker, Chief Med­ical Offi­cer of InflaRx. «We feel encour­aged by these results and are cur­rently plan­ning the ini­ti­a­tion of an inter­na­tional, multi-cen­ter, ran­dom­ized, placebo-con­trolled Phase IIb trial in HS,» he concluded.

InflaRx will present fur­ther details on these results at the 16th Euro­pean Meet­ing on Com­ple­ment in Human Dis­ease, tak­ing place in Copen­hagen from Sep­tem­ber 8 to 12 as well as the 26th Meet­ing of the Euro­pean Acad­emy of Der­ma­tol­ogy and Ven­erol­ogy in Geneva from Sep­tem­ber 13 to 17.

About Hidradeni­tis Suppurativa:
HS is a chronic debil­i­tat­ing sys­temic skin dis­ease which results in painful inflam­ma­tory nod­ules, abscesses and fis­tu­las mostly affect­ing areas with hair fol­li­cles, such as the armpit, groin and gen­i­talia regions. HS patients suf­fer pri­mar­ily from pain and sig­nif­i­cant dis­com­fort result­ing from the con­stant for­ma­tion of pus, often result­ing in social iso­la­tion and a sig­nif­i­cant adverse impact on patients› qual­ity of life. It is esti­mated that approx­i­mately up to 200,000 patients in the United States are suf­fer­ing from mod­er­ate to severe HS, and this num­ber appears to be larger in Europe. The stan­dard of care for HS patients includes top­i­cal, oral or intra­venous antibi­otic treat­ment, which often only pro­vides tem­po­rary symp­to­matic relief. In some cases, patients also undergo surgery. The only approved bio­log­i­cal drug in this indi­ca­tion for mod­er­ate to severe HS patients is an anti-TNF-alpha mon­o­clonal antibody.

About IFX‑1:
IFX‑1 is a first-in-class mon­o­clonal anti-com­ple­ment fac­tor C5a anti­body which offers a com­plete bio­log­i­cal block­ing activ­ity and high selec­tiv­ity towards its tar­get, C5a in human blood. Thus, IFX‑1 leaves the for­ma­tion of the mem­brane attack com­plex (C5b‑9) intact to work 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 the first mon­o­clonal anti-C5a anti­body intro­duced into clin­i­cal devel­op­ment and has, to date, suc­cess­fully com­pleted 3 clin­i­cal phase II stud­ies. In total, over 150 peo­ple have so far been treated with IFX‑1 which was well tol­er­ated. IFX‑1 is cur­rently being devel­oped for dif­fer­ent inflam­ma­tory indications.

About InflaRx:
InflaRx is a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pany focus­ing on apply­ing its pro­pri­etary anti-C5a tech­nol­ogy to dis­cover and develop first-in-class, potent and spe­cific inhibitors of C5a. C5a is a pow­er­ful inflam­ma­tory medi­a­tor involved in the pro­gres­sion of a wide vari­ety of autoim­mune and other inflam­ma­tory dis­eases. The com­pany is also devel­op­ing addi­tional mol­e­cules tar­get­ing chronic and inflam­ma­tion-related dis­eases. InflaRx was founded in 2007 and has offices in Jena and Munich, Ger­many. The team con­sists of renowned experts in com­ple­ment and clin­i­cal research.

Con­tacts:
InflaRx GmbH
Prof. Dr. Niels C. Riede­mann — CEO
Email: info[at]inflarx.de
Tel: +49–3641-508180

MC Ser­vices AG
Katja Arnold / Shaun Brown / Dr. Cora Kaiser
Email: inflarx[at]mc-services.eu
Tel: +49–89-210 2280

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