InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing
anti-inflammatory therapeutics by targeting the complement system,
announced today the commercial launch of Gohibic (vilobelimab) in
the U.S. In April 2023, Gohibic was granted an Emergency Use
Authorization (EUA) by the U.S. Food and Drug Administration (FDA)
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).
Prof. Niels C. Riedemann, Chief Executive
Officer and Founder of InflaRx, commented: “We are excited to make
Gohibic available to certain critically ill COVID-19 patients in
the U.S. Our team is proud to contribute to the fight against this
terrible virus with a potentially lifesaving therapeutic option for
some of the most critically ill COVID-19 patients.”
The data supporting the EUA were based on the
previously announced results of the multicenter Phase III PANAMO
trial, which 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.
Gohibic is currently the only drug directed
against the complement factor C5a that is authorized for the
treatment of certain critically ill COVID-19 patients. InflaRx is
continuing discussions with the FDA related to the submission of a
Biologics License Application (BLA) for a potential future full
approval of Gohibic.
Dr. Thomas Taapken, Chief Financial Officer of
InflaRx, commented: “We have built an excellent core commercial
team to support the launch and distribution to U.S. hospitals. We
also have worked out a time- and cost-efficient model for
distribution. We continue to adapt our investments to create a
commercial and logistical infrastructure as well as additional
manufacturing capacity.”
InflaRx has also completed encouraging meetings
with the rapporteur and co-rapporteur member state 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). The Company will provide updates
on the status of regulatory submissions in the U.S. and elsewhere
once available.
Information for Healthcare Providers
related to Ordering Gohibic (vilobelimab)
Healthcare providers 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).
About the Emergency Use Authorization
(EUA) for Gohibic (vilobelimab)The U.S. 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 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
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 InflaRxInflaRx GmbH
(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.de.
Contacts:
InflaRx N.V.Email:
IR@inflarx.de
MC Services AGKatja Arnold,
Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.euEurope:
+49 89-210 2280U.S.: +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,” “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 or our other
product candidates; our expectations regarding the size of the
patient populations for, market opportunity for, coverage and
reimbursement for and clinical utility of Gohibic 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 U.S. 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 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
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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