InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon R...
March 31 2020 - 3:15PM
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, today announced the enrollment of the first
patient into a randomized clinical trial investigating the safety
and efficacy of IFX-1, the company´s monoclonal anti-C5a antibody,
in patients with severe COVID-19-induced pneumonia. The company has
received initial positive human data from two initial patients
suffering from COVID-19-induced severe pneumonia who were treated
with BDB-001, an anti-C5a antibody produced by BDB from the IFX-1
cell line, in China. Data from the two patients are part of a
larger investigation on the role of complement activation in
COVID-19 which have been made publicly available through a
pre-print server and have not been independently validated by
InflaRx.
Based on the company´s existing pre-clinical
research on the role of C5a in viral-induced pneumonia and the
initial results from the BDB study, InflaRx has decided to initiate
a clinical development program with IFX-1 in COVID-19 patients with
severely progressed pneumonia. The company has received regulatory
approval to start the trial in the Netherlands and enrolled the
first patient at the Amsterdam University Medical Centers. Subject
to regulatory approval, the company plans to initiate additional
centers in Germany and potentially other European countries.
With regard to InflaRx’s other ongoing clinical
trials, the company is monitoring the impact of COVID-19 on its
programs. The company’s current clinical trial sites remain active;
however, it is possible that sites have paused or will pause
screening of new patients, and there may be other delays or
consequences as the pandemic evolves. Therefore, we cannot predict
the future impact on the programs or the company as a whole at
present.
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 inflammatory indications,
including Hidradenitis Suppurativa, ANCA-associated vasculitis and
Pyoderma Gangraenosum.
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.
On December 28, 2015, InflaRx entered into a
co-development agreement with Beijing Defengrei Biotechnology Co.
Ltd., or BDB, for the use of the IFX-1 technology and cell line in
BDB’s development of drug candidates for sale in China. Pursuant to
the agreement, InflaRx granted BDB an exclusive, non-transferable
license to use the IFX-1 cell line and related intellectual
property solely to develop and commercialize BDB’s drug candidates,
including BDB-001, in China. Pursuant to the agreement,
InflaRx is entitled to receive royalties on net sales of BDB’s
products containing BDB-001 and reserves the right to commercialize
products containing BDB-001 outside of China.
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
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “estimate,” “believe,”
“estimate,” “predict,” “potential” or “continue” and similar
expressions. Forward-looking statements appear in a number of
places throughout this release and may include statements regarding
our intentions, beliefs, projections, outlook, analyses and current
expectations concerning, among other things, our ongoing and
planned preclinical development and clinical trials, including with
respect to IFX-1 for the treatment of patients with severe COVID-19
pneumonia, the impact of the COVID-19 pandemic on the company, the
timing of and our ability to commence and conduct clinical trials,
make regulatory filings and obtain and maintain regulatory
approvals for our product candidates, our intellectual property
position, our ability to develop commercial functions, expectations
regarding clinical trial data, our results of operations, cash
needs, financial condition, liquidity, prospects, future
transactions, growth and strategies, the industry in which we
operate, the trends that may affect the industry or us and the
risks uncertainties and other factors described under the heading
“Risk Factors” in InflaRx’s periodic filings with the Securities
and Exchange Commission. These statements speak only as of the date
of this press release and involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and we assume no
obligation to update these forward-looking statements, even if new
information becomes available in the future, except as required by
law.
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