InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, today announced that Gohibic (vilobelimab), a
first-in-class monoclonal anti-human complement factor C5a
antibody, has been granted an Emergency Use Authorization (EUA) by
the U.S. Food and Drug Administration (FDA) for the treatment of
coronavirus disease 19 (COVID-19) in hospitalized adults when
initiated within 48 hours of receiving invasive mechanical
ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Prof. Niels C. Riedemann, CEO and Founder of
InflaRx, said: “We are thrilled and very proud that the FDA has
issued an EUA for vilobelimab to treat this very sick patient
group, recognizing the lifesaving potential of this first-in-class
drug. Despite the availability of vaccines and other treatments for
earlier disease stages of COVID-19, many patients are still
developing viral sepsis and are progressing to critical status,
which often requires invasive mechanical ventilation. As a
consequence, we continue to see mortality rates in the range of
approximately 2,000 COVID-19-reported deaths per week in the U.S.
as reported by the U.S. Centers for Disease Control and Prevention.
Today’s announcement brings new hope to these patients and their
loved ones, and we will work diligently to make this important new
treatment available to patients as rapidly as possible.”
The data supporting the EUA were based on the
previously announced results of the multicenter Phase III PANAMO
trial. PANAMO is one of the largest 1:1 randomized, double-blind
placebo-controlled trials in invasively mechanically ventilated
COVID-19 patients in intensive care units. A total of 369 patients
were randomly assigned to the vilobelimab treatment group (six
800-mg infusions) or the placebo group. Both groups also received
standard of care, which included treatment with anti-coagulants,
dexamethasone and other immunomodulators. The data 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 have been published in The Lancet
Respiratory Medicine.
InflaRx continues discussions with FDA related
to submission of a BLA for full approval of Gohibic in this
COVID-19 indication. InflaRx has also completed encouraging
meetings with the rapporteur and co-rapporteur teams of the
European Committee for Medicinal Products for Human Use (CHMP)
related to a planned Marketing Authorization Application with the
European Medicines Agency (EMA). In addition, InflaRx is continuing
to develop vilobelimab in other indications, including pyoderma
gangrenosum, for which the Company is currently initiating a
Phase III trial.
Prof. Renfeng Guo, M.D., Chief Scientific
Officer and Founder of InflaRx, said: “This EUA is a great
recognition of our COVID-19-related research, which was based on
over two decades of groundbreaking work on the tissue and
organ-damaging effect of the complement factor C5a as part of the
body’s immune response. InflaRx will evaluate broadening our
development of vilobelimab in other areas of viral lung injury and
viral sepsis where the mechanism has already been researched in
pre-clinical models. Our COVID-19 results underscore the
anti-inflammatory potential of inhibition of the terminal C5a and
C5a receptor pathway in other inflammatory diseases.”
Availability and Distribution
InformationInflaRx has a supply of Gohibic (vilobelimab)
available and is working to ramp up production at its third-party
manufacturer to roll out supply in the U.S. as soon as possible.
The Company is assessing all options for supplying drug to
hospitals to enable the treatment of patients. The
Company will provide more detailed information once available.
Conference call scheduled for Wednesday,
April 5, 2023 at 8:30 am EDT/2:30 pm CESTInflaRx will host
a conference call to discuss today’s news on April 5th at 8:30 am
EDT (2:30 pm CEST). To participate in the conference call,
participants may pre-register here and will receive a dedicated
link and dial-in details to easily and quickly access the call. A
replay will be available on the InflaRx website in the Investors -
Events & Presentations section.
About the Emergency Use Authorization
(EUA) for Gohibic (vilobelimab)The US Food and Drug
Administration (FDA) has issued an EUA for the emergency use of
Gohibic for the treatment of COVID-19 in hospitalized adults when
initiated within 48 hours of receiving IMV, or ECMO.
Gohibic has not been approved, but has been
authorized for emergency use by FDA under an EUA, for the treatment
of COVID-19 in hospitalized adults when initiated within 48 hours
of receiving IMV, or ECMO.
The emergency use of Gohibic is only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of the emergency use of drugs
and biological products during the COVID-19 pandemic under Section
564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
declaration is terminated or authorization revoked sooner.
Important Information About Gohibic
(vilobelimab)Vilobelimab is a first-in-class monoclonal
anti-human complement factor C5a antibody that has been granted an
EUA for the treatment of COVID-19 in hospitalized adults when
initiated within 48 hours of receiving invasive mechanical
ventilation (IMV), or extracorporeal membrane oxygenation
(ECMO).
Vilobelimab is an investigational drug that has
not been approved by the FDA for any indication including for the
treatment of COVID-19. There is limited information known about the
safety and effectiveness of using Gohibic to treat people in the
hospital with COVID-19.
Please see additional information in the Fact
Sheet for Healthcare Providers, Fact Sheet for Patients and
Parents/Caregivers and FDA Letter of Authorization on the Gohibic
website (www.gohibic.com).
Important Safety Information About
Gohibic (vilobelimab)There are limited clinical data
available for Gohibic. Serious and unexpected adverse events (AEs)
may occur that have not been previously reported with Gohibic
use.
Gohibic has been associated with an
increase of serious infections. In patients with COVID-19, monitor
for signs and symptoms of new infections during and after treatment
with Gohibic.
Hypersensitivity reactions have been observed
with Gohibic. If a severe hypersensitivity reaction occurs,
administration of Gohibic should be discontinued and appropriate
therapy initiated.
The most common adverse reactions (incidence
≥3%) are pneumonia, sepsis, delirium, pulmonary embolism,
hypertension, pneumothorax, deep vein thrombosis, herpes simplex,
enterococcal infection, bronchopulmonary aspergillosis, hepatic
enzyme increased, urinary tract infection, hypoxia,
thrombocytopenia, pneumomediastinum, respiratory tract infection,
supraventricular tachycardia, constipation, and rash.
Healthcare providers and/or their designee are
responsible for mandatory FDA MedWatch reporting of all medication
errors and serious adverse events or deaths occurring during
Gohibic treatment and considered to be potentially attributable to
Gohibic.
Report side effects to the FDA at
1-800-FDA-1088 or
www.FDA.gov/medwatch. In addition, side
effects can be reported to InflaRx at:
pvusa@inflarx.de
For additional important safety
information, please visit
www.gohibic.com
About Viral Sepsis in SARS-CoV-2
InfectionInvasively 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 InflaRxInflaRx GmbH (in
Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned
subsidiaries of InflaRx N.V. (together “InflaRx”).
InflaRx (Nasdaq: IFRX) is a clinical-stage
biopharmaceutical company focused on applying its proprietary
anti-C5a / C5aR technologies to discover and develop first-in-class
or best-in-class, potent and specific inhibitors of C5a and C5aR.
Complement C5a and its receptor 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, Dr. Regina Lutz Email:
inflarx@mc-services.eu Europe: +49 89-210 2280US:
+1-339-832-0752
FORWARD-LOOKING STATEMENTSThis 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, the status of the EUA for vilobelimab; the timing of
supplying COVID-19 patients with, and the availability of,
vilobelimab; our ongoing and planned pre-clinical development and
clinical trials, including the development of vilobelimab in
several indications; our interactions with regulators regarding the
results of clinical trials and potential regulatory approval
pathways; 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 our 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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