InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients
29 September 2022 - 1:30PM
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, today submitted a request for Emergency Use
Authorization (EUA) following encouraging interactions with the US
Food and Drug Administration (FDA) at a Type B meeting held this
summer. Additionally, InflaRx has been granted Fast Track
designation from the FDA for vilobelimab for the treatment of
critically ill, intubated, mechanically ventilated COVID-19
patients.
The EUA submission and Fast Track designation
are based on the results of the PANAMO trial, one of the largest,
global, 1:1 randomized, placebo-controlled Phase III studies
conducted in invasively mechanically ventilated, critically ill
COVID-19 patients. The detailed results of the study were recently
published in the peer-reviewed journal, The Lancet Respiratory
Medicine.
Prof. Niels C. Riedemann, CEO and Founder of
InflaRx, said: “The EUA submission is an exciting milestone for
InflaRx in the development of our lead candidate, vilobelimab. We
believe that the data from our Phase III study strongly support the
potential of vilobelimab to reduce the number of deaths in
critically ill, invasively mechanically ventilated COVID-19
patients. Patients are still progressing to this critical status
despite the availability of vaccines and other treatments for
earlier disease stages and continue to show high mortality
rates.”
He continued: “The FDA’s granting of Fast Track
designation for vilobelimab in this indication underscores the need
for effective new therapies to treat COVID-19 patients who have
progressed to critical disease with viral sepsis and organ failure.
We look forward to working with the FDA on the review of our
application with the goal of making vilobelimab available to
patients in need.”
The FDA’s Fast Track designation is designed to
facilitate the development and expedite the review of treatments
for serious medical conditions, thereby addressing unmet medical
needs. Therapies that are included in this program may be eligible
for more frequent interactions with the FDA to discuss the
development path, and, if the program criteria are met, eligibility
for a potential Rolling Review, Accelerated Approval, and Priority
Review.
About Vilobelimab Vilobelimab
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, vilobelimab 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. Vilobelimab has been demonstrated in pre-clinical
studies to control the inflammatory response driven tissue and
organ damage by specifically blocking C5a as a key “amplifier” of
this response. Vilobelimab is believed to be the first monoclonal
anti-C5a antibody introduced into clinical development. Vilobelimab
has been shown to be well tolerated within clinical trials in
different disease settings. Vilobelimab is currently being
developed for various indications, including pyoderma gangrenosum
and critical COVID-19. Vilobelimab is also in Phase II development
for patients suffering from cutaneous squamous cell carcinoma.
The COVID-19 related work described herein is
partly funded by the German Federal Government through grant number
16LW0113 (VILO-COVID). All responsibility for the content of this
work lies with InflaRx.
About InflaRx N.V.InflaRx
(Nasdaq: IFRX) is a clinical-stage biopharmaceutical company
focused on applying its proprietary technology to discover and
develop first-in-class or best-in-class, potent and specific
inhibitors of C5a and C5aR. Complement C5a and C5aR are powerful
inflammatory mediators 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.Email: IR@inflarx.de
MC Services AGKatja Arnold,
Laurie Doyle, Andreas Jungfer Email: inflarx@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,” “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
pre-clinical development and clinical trials, including the
development of vilobelimab in several indications, including to
treat pyoderma gangrenosum (PG) and critical COVID-19; our
interactions with regulators regarding the results of clinical
trials and potential regulatory approval pathways; our submission
of an application to the FDA for emergency use authorization for
vilobelimab to treat critical COVID-19 and the FDA’s review of the
application; the impact of the COVID-19 pandemic on us; the timing
and our ability to commence and conduct clinical trials; potential
results from current or potential future collaborations; our
ability to make regulatory filings, obtain positive guidance from
regulators, 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; decisions regarding the strategic direction of our
business; 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’
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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