InflaRx Pharmaceuticals Inc., a subsidiary of InflaRx N.V. (Nasdaq:
IFRX), a biopharmaceutical company pioneering anti-inflammatory
therapeutics by targeting the complement system, announced today
that the Company has launched The InflaRx Commitment Program
(Commitment Program). Pursuant to the Commitment Program, the cost
of GOHIBIC (vilobelimab) will be refunded for up to six (6)
administered inpatient doses (the full treatment course) to
institutions that meet the eligibility requirements*, for patients
who were administered GOHIBIC in line with its EUA and who died due
to COVID-19 in the intensive care unit.
In April 2023, the U.S. Food and Drug
Administration (FDA) issued an EUA for GOHIBIC for the treatment of
COVID-19 in hospitalized adults when initiated within 48 hours of
the patient receiving invasive mechanical ventilation (IMV) or
extracorporeal membrane oxygenation (ECMO). While GOHIBIC has been
FDA authorized, it is not FDA approved for this use.
The Commitment Program is designed to encourage
medical facilities across the United States to stock GOHIBIC, since
the initiation of treatment is time critical, and to ultimately
provide the opportunity for patients to access this potentially
life-saving therapy.
According to the Centers for Disease Control,
there has been a recent increase in COVID-19 fatality rates, with
reported deaths related to this disease in the range of 1,500
deaths per week in the U.S.1
Christian Sandrock, M.D., M.P.H., FCCP, Division
Vice Chair of Internal Medicine, Director of Critical Care,
Professor of Medicine, UC Davis Health, said: “Once a patient with
COVID-19 reaches the point of intubation, there are extremely
limited treatments available outside of supportive care and
mechanical ventilatory support. With COVID-19 deaths again on the
rise, it is critical that doctors have access to more therapies to
help save the lives of these patients, particularly for those that
have progressed to require mechanical ventilation. With the
emergency use authorization of GOHIBIC, the FDA recognized a
critical unmet need and provided those of us on the frontlines,
fighting this disease, an important new option which has been
specifically developed as a potentially life-saving therapy for
these sickest patients.”
He added: “Many hospitals struggle to provide
patient access to all available medicines, even those that may be
lifesaving. So, it is reassuring that InflaRx is willing to
reimburse the cost of their medicine in cases where the patient
does not survive. This shows me that InflaRx is confident in their
product, is doing everything it can to support hospitals and get
GOHIBIC to patients who are in critical need of intervention.”
Prof. Niels C. Riedemann, Chief Executive
Officer, and Founder of InflaRx, commented: “COVID-19 continues to
take far too many lives. Despite this unacceptable situation,
patients do not always have access to approved or authorized
treatment options. With today´s announcement, we are demonstrating
our strong commitment to help make GOHIBIC available for the most
affected COVID-19 patients as a potential life-saving therapy.
There are currently no approved or authorized alternatives to
GOHIBIC, and we believe that all eligible patients and the
physicians responsible for their care should have access to this
treatment.”
The data supporting the EUA for GOHIBIC was
based on a 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 treatment with GOHIBIC 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 has
been published in The Lancet Respiratory Medicine. GOHIBIC is the
only drug directed against the complement factor C5a that is
authorized for the treatment of certain critically ill COVID-19
patients.
Information for Healthcare Facilities
for Ordering GOHIBIC (vilobelimab)Healthcare facilities
can order GOHIBIC from ASD Healthcare (i) by calling 1-800-746-6273
or (ii) by e-mailing service@asdhealthcare.com. Please provide the
product and notational drug code (NDC): GOHIBIC (NDC
83000-0110-04).
For detailed information about the Commitment
Program and to file a claim, please visit this link: The InflaRx
Commitment Program.
About the EUA for GOHIBIC
(vilobelimab)The 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 IMV or 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 the full prescribing information and
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 VilobelimabVilobelimab 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.
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 biotechnology
company pioneering anti-inflammatory therapeutics by applying its
proprietary anti-C5a and anti-C5aR technologies to discover,
develop and commercialize highly 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, the receptiveness of Gohibic (vilobelimab) as a
treatment for COVID-19 by COVID-19 patients and U.S. hospitals and
related treatment recommendations by medical/healthcare institutes
and other third-party organizations, our ability to successfully
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 Emergency Use Authorization and in the future
if approved for commercial use in the United States or elsewhere;
our ability to successfully implement the Commitment Program, the
success of our future clinical trials for vilobelimab’s treatment
of COVID-19 and other debilitating or life-threatening inflammatory
indications, including pyoderma gangrenosum, and any other product
candidates, including INF904, and whether such clinical results
will reflect results seen in previously conducted pre-clinical
studies and clinical trials; the timing, progress and results of
pre-clinical studies and 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 Marketing Authorization Application submission for
vilobelimab and our biologics license application submission for
Gohibic (vilobelimab), and our ability to obtain and maintain full
regulatory approval of vilobelimab or Gohibic (vilobelimab) for any
indication; whether the U.S. Food and Drug Administration, the
European Medicines Agency 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
U.S. 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.
______________________________________
* Eligibility Requirements, Terms and Conditions
apply. Please see the full Terms and Conditions provided on the
webpage: The InflaRx Commitment Program.
1 Centers for Disease Control and Prevention.
COVID data tracker.
InflaRx NV (NASDAQ:IFRX)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
InflaRx NV (NASDAQ:IFRX)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024