InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering
anti-inflammatory therapeutics by targeting the complement system,
announced today that GOHIBIC (vilobelimab) has been selected by the
Biomedical Advanced Research and Development Authority (BARDA),
part of the Administration for Strategic Preparedness and Response
within the U.S. Department of Health and Human Services, as one of
three investigational therapies to be assessed in a Phase 2
clinical platform study exploring potential new options for the
treatment of acute respiratory distress syndrome (ARDS).
Prof. Niels C. Riedemann, Chief
Executive Officer and Founder of InflaRx, commented: “It’s
a tremendous privilege for InflaRx that BARDA has chosen
vilobelimab for inclusion in this pioneering ARDS program. ARDS is
one of the most pressing unmet needs in critical care today, with
no approved therapy, and we’re delighted to expand our dedication
to the community with this study made possible by this non-dilutive
path to trial participation. Given vilobelimab’s potent inhibition
of C5a and a host-directed mechanism of action, we believe it has
the potential for broader applicability as a potent
anti-inflammatory agent in ARDS."
The Phase 2 multicenter, randomized,
double-blind, placebo-controlled trial is expected to begin later
this year. It is carried out by a global clinical research
organization (CRO), PPD Development, LP (a clinical research
business of Thermo Fisher Scientific, Inc.), contracted by BARDA.
The trial is expected to be conducted at approximately 60 sites in
the U.S., with a total target enrollment of 600 hospitalized adults
with ARDS. Enrollment will include ARDS due to any etiology other
than trauma, large volume aspiration, or transfusion. ARDS severity
will be defined prospectively.
Vilobelimab, which will be supplied by InflaRx
from its available stock, will be one of three host-directed
investigational drugs assessed in this study, with the safety and
efficacy of each investigational drug to be studied in its own
patient cohort and compared against placebo. Each cohort is
expected to enroll 200 patients (100 on investigational drug and
100 on placebo), with both arms in each cohort including standard
of care as background therapy.
The primary endpoint will be all-cause mortality
at Day 28, with additional efficacy endpoints to include all-cause
mortality at additional time periods, days of hospitalization, days
in the ICU, daily oxygenation requirements, invasive mechanical
ventilation endpoints, as well as other efficacy endpoints and
biomarker measures.
This Phase 2 platform study will collect data in
order to define subsets of patients with ARDS who may benefit from
specific host-directed therapeutics. These data will inform the
design of Phase 3 studies and identify a patient subpopulation most
likely to benefit from each of the three drug candidates.
About ARDSARDS is a
life-threatening lung condition with multiple causes, including
severe pneumonia and sepsis due to bacterial and viral infections
such as influenza and SARS-CoV-2, that leads to high rates of death
among hospitalized patients. ARDS is believed to be driven by the
body’s immune response to an underlying inflammatory insult, also
known as host response, which has been demonstrated to contribute
to lung inflammation and tissue damage in multiple pre-clinical
studies. Currently, no approved or licensed medications are
available to treat ARDS.
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.
About C5a in ARDSObservational
and pre-clinical studies have suggested that the inflammatory host
response, the associated tissue damage through endothelial
permeability increase, and coagulopathy observed in ARDS are
associated with strong complement activation and C5a generation as
part of the innate immune response. By targeting the complement
component C5a, vilobelimab is believed to block a key mediator of
this inflammatory host response and, thus, potentially offers a
mechanism of action that may be relevant to organ damage and
associated mortality in ARDS. 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 studies investigating vilobelimab in influenza, as well
as chemically induced lung damage. A recent placebo-controlled, 1:1
randomized, multinational, multicenter study in patients with
evidence of SARS-CoV-2 infection who required invasive mechanical
ventilation (IMV) or lung replacement therapy (ECMO) has
demonstrated a significant 28-day and 60-day survival improvement,
which was the basis for an emergency use authorization (EUA) of
GOHIBIC (vilobelimab).
Important Information about GOHIBIC
(vilobelimab)Vilobelimab has been granted 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.
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 InflaRx N.V.: 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 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 is also developing INF904, an orally
administered small molecule inhibitor of C5a-induced signaling via
the C5a receptor. 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. |
MC Services AG |
Jan Medina, CFAVice President, Head of Investor RelationsEmail:
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 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 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 EUA and in the future if approved for
commercial use in the U.S. or elsewhere; our ability to
successfully implement The InflaRx 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 PG, 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 MAA 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 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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