InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering
anti-inflammatory therapeutics by targeting the complement system,
announced data presented at the American Thoracic Society (ATS)
2024 International Conference that is being held from May
17-22, 2024 in San Diego.
InflaRx is presenting a poster at the thematic
poster session at the ATS conference today from 11:30 AM PT / 2:30
PM ET to 1:15 PM PT / 4:15 PM ET. The poster is titled,
“Vilobelimab in Combination with Tocilizumab or Baricitinib
Dramatically Improves Mortality in Critically Ill COVID-19
Patients” and is being presented during the “ARDS and Acute
Respiratory Failure: Mechanism, Risk, and Outcomes” thematic poster
session.
The data being presented is derived from a
post-hoc subgroup analysis of the PANAMO Phase III global study,
one of the largest 1:1 randomized, double-blind placebo-controlled
trials in invasively mechanically ventilated (IMV) COVID-19
patients in intensive care units in adult critically ill COVID-19
patients. Tocilizumab, an anti-IL6R antibody, and baricitinib, a
JAK inhibitor, are immunomodulators used in some patients as part
of the standard of care treatment in this trial. PANAMO included a
total of 369 patients and was used to support the emergency use
authorization (EUA) granted by the U.S. Food and Drug
Administration (FDA) in April 2023 for GOHIBIC (vilobelimab) for
the treatment of critically ill COVID-19 patients.
The analysis presented at ATS 2024 is comprised
of 71 patients from PANAMO that assessed 28- and 60-day all-cause
mortality in the subgroup of patients taking the combination of
vilobelimab plus tocilizumab or baricitinib versus patients on
placebo plus tocilizumab or baricitinib. All patients received
standard of care. Safety was also assessed.
The point estimate for 28-day all-cause
mortality was 6.3% in the vilobelimab plus tocilizumab or
baricitinib arm, and 40.9% in the placebo plus tocilizumab or
baricitinib arm: this is a significant relative reduction of 84.6%
(HR 0.13; 95% CI:0.03-0.56, p=0.006) between the two arms. Day 60
all-cause mortality was 16.4% and 49.3%, respectively (HR 0.25; 95%
CI:0.09-0.68, p=0.006), a significant relative reduction.
The co-administration of vilobelimab with
baricitinib or tocilizumab was not associated with safety concerns.
In addition, demographics of these subgroups were generally
well-balanced and comparable to the overall study population.
Camilla Chong, MD, Chief Medical Officer
of InflaRx, commented: “I am thrilled that we can share
this additional data from the PANAMO study, which will provide
further scientific insights into the utility of vilobelimab when
used with tocilizumab and baricitinib in critically ill
hospitalized COVID-19 patients. We believe this analysis further
supports the life-saving potential of vilobelimab in the acute care
setting and indicates our continued commitment to these
patients.”
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.
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 extracorporeal membrane
oxygenation.
The emergency use of GOHIBIC (vilobelimab) 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 (vilobelimab) 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 (vilobelimab) website (www.GOHIBIC.com).
Important Safety Information about
GOHIBIC (vilobelimab)There is limited clinical data
available for GOHIBIC (vilobelimab). Serious and unexpected adverse
events (AEs) may occur that have not been previously reported with
GOHIBIC (vilobelimab) use.
GOHIBIC (vilobelimab) 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 (vilobelimab). Hypersensitivity reactions
have been observed with GOHIBIC (vilobelimab). If a severe
hypersensitivity reaction occurs, administration of GOHIBIC
(vilobelimab) 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 AEs or deaths occurring during GOHIBIC
(vilobelimab) treatment and considered to be potentially
attributable to GOHIBIC (vilobelimab).
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 biopharmaceutical
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 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 FDA, 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
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.
InflaRx NV (NASDAQ:IFRX)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
InflaRx NV (NASDAQ:IFRX)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024