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First filed for registration in the Netherlands
Regulatory approval granted to start testing in Germany
Additional sites to be added in the US, EU and regions
Encourage knowledge of Phase II accepted for publication in The Lancet Rheumatology
JENA, Germany, 14 September 2020 (GLOBE NEWSWIRE) – InflaRx (Nasdaq: IFRX), a clinically staged biopharmaceutical company that presents anti-inflammatory treatments targeting the supplement system, today announced the start of the global Phase III trial of its Phase II/III Trial with IFX-1 in COVID-19-induced severe pneumonia at the start of the first clinic in the Netherlands. At the same time, the German regulator, the Paul Ehrlich Institute (PEI), approved phase III clinical trial in Germany.
The randomized, double-blind, placebo-controlled phase III part of the Phase II/III trial plans to recruit approximately 360 early and severely ill intubated patients with COVID-19-induced pneumonia at sites in the United States, EU, South America, and other regions. Patients will be randomized 1: 1 to get IFX-1 or a placebo; all patients will get popular care. The number one valuation criterion will be all-cause mortality at 28 days; The main secondary assessment criteria will come with organ evaluation and disease improvement. An interim investigation is planned after the recruitment of 180 patients, with the prospect of early termination by efficacy or futility.
Dr. Korinna Pilz, Global Director, R
Data from the phase II component of the study, which evaluated IFX-1 plus the most productive supportive care and supportive care in 30 patients, were accepted for publication in the peer-reviewed journal, The Lancet Rheumatology.
Dr Alexander Vlaar, lead researcher in the study at the University of Amsterdam, Department of Intensive Care Medicine, commented: “We are very pleased that a leading and peer-reviewed journal has identified the importance of Phase II knowledge for patients with severe COVID-19. induced pneumonia. The effects demonstrate promising early efficacy signals, which adds a decrease in organ mortality and rates of disorders, and recommends that C5a inhibition possibly occur in patients with severely ill COVID-19. Proof.
IFX-1, which recently received the International Joint Name (ICI), vilobelimab, is recently conducting more Phase II studies on ANCA-related vascularitis and Pyoderma Gangraenosum and has completed phase IIb progression in the alleged synerade, for which a Phase III clinic is developing a progression strategy.
About IFX-1:
IFX-1 is a world-class C5a monoclonal antifactor antibody that strongly and well blocks the biological activity of C5a and demonstrates superior selectivity towards its target in human blood. Therefore, IFX-1 leaves intact the formation of the membrane attack complex (C5b-9) as a vital defense mechanism, which is not the case for molecules that block C5 excision. IFX-1 has been shown to affect tissue and organ lesions induced through the inflammatory reaction, in particular by blocking C5a as a key “amplifier” of this reaction. IFX-1 is believed to be the first anti-C5a monoclonal antibody introduced in clinical development. Approximately three hundred other people were treated with IFX-1 in clinical trials and the antibody was found to be well tolerated. 1 is evolving lately for various indications, adding sputum hydride, ANCA-associated vascularitis, pyoderma gangraenosum and COVID-19 pneumonia.
About InflaRx N. V. :
InflaRx (Nasdaq: IFRX) is a clinically staged biopharmaceutical company that aims to apply its patented anti-C5a generation to detect and expand world-class, resistant and express C5a inhibitors. wide variety of autoimmune diseases and other inflammatory diseases. InflaRx was founded in 2007 and the organization has offices and subsidiaries in Jena and Munich, Germany, as well as in Ann Arbor, MI, USA. For more information, visit www. inflarx. com.
Contacts:
InflaRx N. V. Jordan Zwick – Global Director of Business Development and Corporate Strategy Email: jordan. zwick [at] inflarx. deTél: 1917-338-6523
Services of MC AGKatja Arnold, Laurie Doyle, Andreas Jungfer Email: inflarx [at] mc-services. eu Europe: 89-210 2280US: 1-339-832-0752
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