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inflarx nv (IFRX) Details

InflaRx N.V., a clinical-stage biopharmaceutical company, discovers and develops inhibitors using C5a technology primarily in the United States and Europe. Its C5a is an inflammatory mediator is involved in the enhancement of a variety of autoimmune and other inflammatory diseases. The company's lead product candidate is IFX-1, an intravenously delivered first-in-class anti-C5a monoclonal antibody, which completed the Phase II clinical trial for the treatment of hidradenitis suppurativa, a rare and chronic debilitating systemic inflammatory skin disease; to treat ANCA-associated vasculitis, a rare and life-threatening autoimmune disease; and for the treatment of pyoderma gangrenosum, a chronic inflammatory skin disorder, as well as developing IFX-1 for the treatment of oncological diseases. It also develops IFX-2 that is in pre-clinical development stage for the treatment of chronic inflammation and autoimmune diseases. The company has co-development agreement with Beijing Defengrei Biotechnology Co. Ltd. The company was formerly known as Fireman B.V. and changed its name to InflaRx N.V. in 2017. InflaRx N.V. was founded in 2007 and is headquartered in Jena, Germany.

36.8 Employees
Last Reported Date: 03/28/19
Founded in 2007

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inflarx nv
InflaRx N.V. - Special Call

To discuss additional analysis of the SHINE Phase IIb Results for IFX-1 in Hidradenitis Suppurativa

InflaRx N.V. Reports Additional In-depth Analysis of the Completed Double Blind, Placebo Controlled Part of the Ongoing International SHINE Phase IIb study

InflaRx N.V. reported additional in-depth analysis of the completed double blind, placebo controlled part of the ongoing international SHINE Phase IIb study to supplement InflaRx’s top line disclosure of results reported on June 5, 2019. The purpose of this study is to investigate the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody, in patients suffering from moderate to severe Hidradenitis Suppurativa, a painful and debilitating chronic inflammatory skin disease with limited treatment options. The randomized, double-blind, placebo-controlled, multicenter study, which enrolled a total of 179 patients in four active dose arms and a placebo arm at over 40 sites in North America and Europe, recently reported a failure to achieve its primary endpoint, a dose dependent drug effect on Hidradenitis Suppurativa Clinical Response Score. In order to be a responder in this binary score, the total body count of abscesses and inflammatory nodules must be reduced by at least 50% while the abscesses and draining fistula count may not accede baseline counts. The score thus does not account for any reduction in draining fistulas. The placebo arm demonstrated an unusually high HiSCR response rate at week 16 of 47.2%, when compared to earlier reported larger studies (Pioneer 1: 26% /Pioneer 2: 27.6%, both at week 12). An in-depth patient by patient data analysis revealed a very high variability of the HiSCR responses in all trial groups, which was strongly affected by a large individual fluctuation of the AN count. The inclusion and exclusion criteria of the SHINE study were nearly identical to the ones used in an earlier published trial, the PIONEER II study, and the baseline characteristics of the placebo group in the SHINE study were comparable to those of the PIONEER II study with a good distribution across all dose groups. This accounts especially for the median AN count, median draining fistula count, gender distribution, Hurley Stage II and III distribution and others. Despite various additional efforts including post-hoc sensitivity analysis on parameters like differences in HiSCR responder rates in patients with low or high AN count at baseline, in Hurley II versus III patients, in severe versus moderately diseased patients, as well as clinical trial-site analysis, and several others, the profound difference in the HiSCR response rates between these two trials could not be explained by the results of these analyses. Importantly, no underlying trial conduct problem to account for the high placebo HiSCR rate could be detected. InflaRx conducted an in-depth efficacy analysis (secondary endpoints as well as additional post-hoc analysis) upon receipt of the full data set of the first 16 weeks of the SHINE study and, consecutively, consulted with key opinion leaders and members of its Scientific Steering Committee in the United States, Canada and Europe. This analysis revealed multiple efficacy signals for the high dose group when compared to the placebo group: At week 16, there was a statistically significant reduction of draining fistulas relative to baseline in the high dose IFX-1 group when compared to placebo This reduction in DF was visible as early as 2 weeks after induction of high dose IFX-1 therapy and consistent over time with the strongest observed reductions seen at weeks 6, 8 and 16. A temporary weakening of the strong reduction was observed between weeks 10 to 14 which could not be explained by pharmacokinetic or pharmacodynamic parameters. The strong relative reduction of draining fistulas observed in the SHINE trial was consistent with earlier findings in the open label Phase IIa study. IFX-1 therapy reduced the AN count at week 16 relative to baseline with a trend to a dose dependent effect. Further analysis showed that high dose IFX-1 therapy reduced abscesses and inflammatory nodule counts over time.

Inflarx N.V Announces Resignation of Tony Gibney as Director

Effective June 11, 2019, Tony Gibney resigned as a Director of the Board of Directors of InflaRx N.V. due to a requirement of his current employer.

 

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