InflaRx Announces Initiation of Phase III Part of Phase II/III Clinical Trial with IFX-1 in Severe COVID-19 Induced Pneumonia...
September 14 2020 - 7:30AM
InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, announced today the start of the global Phase
III part of its Phase II/III trial with IFX-1 in severe COVID-19
induced pneumonia with the initiation of the first clinical site in
the Netherlands. In parallel, the German regulatory authority, the
Paul-Ehrlich-Institut (PEI), has approved the Phase III clinical
trial in Germany.
The randomized, double-blinded and
placebo-controlled Phase III part of the Phase II/III trial plans
to enroll approximately 360 early intubated, critically ill
patients with COVID-19 induced pneumonia across sites in the US,
EU, South America and other regions. Patients will be randomized
1:1 to receive either IFX-1 or placebo; all patients will receive
standard of care. The primary endpoint will be 28-day all-cause
mortality; key secondary endpoints will include assessment of organ
support and disease improvement. An interim analysis is planned
after enrollment of 180 patients, with a potential for an early
stop for efficacy or futility.
Dr. Korinna Pilz, Global Head of Clinical
R&D at InflaRx, noted: “Encouraged by our initial Phase II
results, we are now rolling out the international Phase III part of
the trial. Our team is driven by the prospect of adding to the
global efforts in the fight against this pandemic and by advancing
the development of a potential therapeutic for the sickest COVID-19
patients.”
The data from the Phase II part of the study,
which evaluated IFX-1 treatment plus best supportive care and best
supportive care alone in 30 patients, have been accepted for
publication in the peer-reviewed journal, The Lancet
Rheumatology.
Dr. Alexander Vlaar, the principal investigator
of the study from Amsterdam University, Department of Intensive
Care Medicine, commented: “We are very pleased that a
distinguished, peer-reviewed journal has recognized the
significance of the Phase II data for patients with severe COVID-19
induced pneumonia. The results demonstrate promising early efficacy
signals, including lower mortality and organ dysfunction rates, and
suggest that C5a inhibition might be beneficial in critically ill
COVID-19 patients. However, these effects need to be confirmed in
the large, well-powered Phase III part of the trial.”
IFX-1, which has recently been granted the
International Nonproprietary Name (INN), vilobelimab, currently has
additional ongoing Phase II studies in ANCA-associated vasculitis
and Pyoderma Gangraenosum and has completed Phase IIb development
in Hidradenitis Suppurativa, for which a Phase III clinical
development strategy is currently being developed.
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 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 StrategyEmail:
jordan.zwick[at]inflarx.deTel: +1 917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas Jungfer Email: inflarx[at]mc-services.eu
Europe: +49 89-210 2280US: +1-339-832-0752
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