InflaRx N.V. (Nasdaq: IFRX), a biotechnology company
pioneering anti-inflammatory therapeutics targeting the complement
system, announced today that the Company has submitted a Marketing
Authorization Application (MAA) for the treatment of adult patients
with SARS-CoV-2 induced septic acute respiratory distress syndrome
(ARDS) receiving invasive mechanical ventilation (IMV) or
extracorporeal membrane oxygenation (ECMO) and that the European
Medicines Agency (EMA) has validated the MAA. This means that the
application is now under regulatory review by the European
Committee for Medicinal Products for Human Use (CHMP) under the
centralized procedure, which applies to all 27 member states of the
European Union (EU).
InflaRx submitted the MAA to EMA in July 2023
following interactions with the rapporteur and co-rapporteur teams
of the CHMP. The MAA submission is based on the previously
announced results of the multicenter Phase III PANAMO trial, one of
the largest 1:1 randomized, double-blind placebo-controlled trials
in invasively mechanically ventilated COVID-19 patients in
intensive care units. The results showed that vilobelimab treatment
improved survival with a relative reduction in 28-day all-cause
mortality of 23.9% compared to placebo in the global data set. The
data were published in The Lancet Respiratory Medicine.
“We are pleased that EMA has accepted our MAA
submission and that it is now under review. By targeting the
complement component C5a, vilobelimab blocks what is believed to be
a key mediator of the tissue damaging inflammatory host response
induced by severe SARS-CoV-2 infection. Based on the data from our
Phase III trial, we believe that our treatment approach can make a
meaningful difference for critically ill COVID-19 patients who are
invasively mechanically ventilated,” said Dr. Camilla Chong, Chief
Medical Officer of InflaRx.
“We look forward to continuing to work closely
with EMA throughout the MAA review process, which is another
important step toward our goal of bringing a potential treatment
option to certain critically ill COVID-19 patients in Europe after
having recently received an Emergency Use Authorization (EUA) in
the United States,” added Derval O’Carroll, Senior Vice President
and Global Head of Regulatory Affairs & Compliance at
InflaRx.
Gohibic (vilobelimab) has received an EUA in the
U.S. for the treatment of COVID-19 in hospitalized adults when
initiated within 48 hours of receiving IMV or ECMO. The Company is
continuing discussions with the Food and Drug Administration (FDA)
related to the submission of a Biologics License Application (BLA)
for a potential future full approval of Gohibic (vilobelimab) in
the United States. For additional information related to the EUA,
please visit www.Gohibic.com
Upcoming scientific and investor
events
InflaRx’s management will participate in the
following conferences in the coming weeks:
World Antimicrobial Resistance CongressSeptember
7-8, 2023, Philadelphia, PA, USA
- Panel discussion, September 7,
11:20 am EDT with Prof. Niels C. Riedemann, CEO
H.C. Wainwright 25th Annual Global Investment
Conference September 11-13, 2023, New York, NY, USA
- Company presentation on September
11th, 11:00 am EDT (webcast)
7th Annual Complement-Based Drug Development
SummitSeptember 11-13, 2023, Boston, MA, USA
- Presentation “The Life-Saving
Anti-Inflammatory Potential of Blocking the C5a / C5aR Signaling
Pathway,” by Prof. Riedemann, September 12th, 5:10 pm EDT
- Panel “What are
the Future Applications of Complement Therapeutics; What Will the
Landscape Look Like in 5 Years’ Time?,” September 13th, 4:30 pm
EDT
BioPharm America 2023 September 11-13, 2023,
Research Triangle Park, USA
- Scheduled corporate and investor
meetings
Guggenheim Securities 5th Annual Inflammation
& Immunology (I&I) Conference November 6-7, 2023, New York,
NY, USA
BIO-Europe®November 6-8, 2023, Munich,
Germany
- Company presentation and scheduled
corporate and investor meetings
About Viral Sepsis in SARS-CoV-2
Infection
Invasively mechanically ventilated patients who
have tested positive for COVID-19 fulfill the criteria set by the
current third international consensus definitions for sepsis, which
define sepsis as a “life-threatening organ dysfunction caused by a
dysregulated host response to infection.” Viral infection-mediated
sepsis is believed to be driven by the inflammatory immune response
of a patient to the virus. Observational studies have suggested
that the inflammatory response, endothelial permeability and
coagulopathy observed in severe COVID-19 are associated with strong
complement activation and C5a generation as part of the human
innate immune response. By targeting the complement component C5a
in critically ill and invasively mechanically ventilated COVID-19
patients, vilobelimab is believed to block a key mediator of this
inflammatory host response induced by severe SARS-CoV-2 infection
and, thus, potentially offers a mechanism of action that may be
independent of the viral variant that has caused such inflammatory
response. Inhibition of the C5a / C5aR pathway has been
demonstrated to be beneficial or lifesaving in various pre-clinical
models of viral lung injury and viral sepsis, including models
investigating influenza and corona viruses.
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 of the innate immune system, which is not the case for
molecules blocking C5. In pre-clinical studies, vilobelimab has
been shown to control the inflammatory response driven tissue and
organ damage by specifically blocking C5a as a key “amplifier” of
this response. In addition to development in COVID-19, vilobelimab
is also being developed for various debilitating or
life-threatening inflammatory indications, including pyoderma
gangrenosum and 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
InflaRx GmbH (Germany) and InflaRx
Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx
N.V. (together, “InflaRx”).
InflaRx (Nasdaq: IFRX) is a biotechnology
company pioneering anti-inflammatory therapeutics by applying its
proprietary anti-C5a and anti-C5aR technologies to discover,
develop and commercialize first-in-class, potent and specific
inhibitors of the complement activation factor C5a and its receptor
C5aR. C5a is a powerful inflammatory mediator involved in the
progression of a wide variety of inflammatory diseases. InflaRx’s
lead product candidate, vilobelimab, is a novel, intravenously
delivered, first-in-class, anti-C5a monoclonal antibody that
selectively binds to free C5a and has demonstrated
disease-modifying clinical activity and tolerability in multiple
clinical studies in different indications. 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. |
MC Services AG |
Email: IR@inflarx.de |
Katja Arnold, Laurie Doyle, Dr. Regina LutzEmail:
inflarx@mc-services.eu Europe: +49 89-210 2280U.S.:
+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,”
“predict,” “potential” or “continue,” among others. 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 ability to commercialize and the
receptiveness of Gohibic (vilobelimab) as a treatment for COVID-19
by COVID-19 patients and U.S. hospitals or our other product
candidates; our expectations regarding the size of the patient
populations for, market opportunity for, coverage and reimbursement
for, estimated returns and return accruals for, and clinical
utility of Gohibic (vilobelimab) in its approved or authorized
indication or for vilobelimab and any other product candidates,
under an EUA and in the future if approved for commercial use in
the United States or elsewhere; the success of our future clinical
trials for vilobelimab and any other product candidates and whether
such clinical results will reflect results seen in previously
conducted pre-clinical studies and clinical trials; the timing,
progress and results of clinical trials of our product candidates,
and statements regarding the timing of initiation and completion of
studies or trials and related preparatory work, the period during
which the results of the trials will become available, the costs of
such trials and our research and development programs generally;
our interactions with regulators regarding the results of clinical
trials and potential regulatory approval pathways, including
related to our MAA submission for vilobelimab and our BLA
submission for Gohibic (vilobelimab), and our ability to obtain and
maintain full regulatory approval of vilobelimab or Gohibic
(vilobelimab) for any indication; whether the FDA, the EMA, or any
comparable foreign regulatory authority will accept or agree with
the number, design, size, conduct or implementation of our clinical
trials, including any proposed primary or secondary endpoints for
such trials; our expectations regarding the scope of any approved
indication for vilobelimab; our ability to leverage our proprietary
anti-C5a and C5aR technologies to discover and develop therapies to
treat complement-mediated autoimmune and inflammatory diseases; our
ability to protect, maintain and enforce our intellectual property
protection for vilobelimab and any other product candidates, and
the scope of such protection; our manufacturing capabilities and
strategy, including the scalability and cost of our manufacturing
methods and processes and the optimization of our manufacturing
methods and processes, and our ability to continue to rely on our
existing third-party manufacturers and our ability to engage
additional third-party manufacturers for our planned future
clinical trials and for commercial supply of vilobelimab and for
the finished product Gohibic (vilobelimab); our estimates of our
expenses, ongoing losses, future revenue, capital requirements and
our needs for or ability to obtain additional financing; our
ability to defend against liability claims resulting from the
testing of our product candidates in the clinic or, if approved,
any commercial sales; if any of our product candidates obtain
regulatory approval, our ability to comply with and satisfy ongoing
obligations and continued regulatory overview; our ability to
comply with enacted and future legislation in seeking marketing
approval and commercialization; our future growth and ability to
compete, which depends on our retaining key personnel and
recruiting additional qualified personnel; and our competitive
position and the development of and projections relating to our
competitors in the development of C5a and C5aR inhibitors or our
industry; and the risks, uncertainties and other factors described
under the heading “Risk Factors” in our periodic filings with the
SEC. 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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