InflaRx N.V. (Nasdaq: IFRX), a biotechnology company
pioneering anti-inflammatory therapeutics targeting the complement
system, announced today that the first patient has been dosed in
its Phase III study investigating the efficacy and safety of
vilobelimab in ulcerative PG, a rare neutrophilic and inflammatory
skin disease characterized by destructive, painful cutaneous
ulcers.
“We are pleased that the first patient has been
dosed in the U.S. in our pivotal Phase III study with vilobelimab
for the treatment of ulcerative pyoderma gangrenosum. There are
currently no approved treatments for this debilitating disease in
either the U.S. or Europe, and therefore, there remains a high
unmet medical need for these patients,” said Dr. Camilla Chong, MD,
Chief Medical Officer of InflaRx. “The Phase III study builds
on our promising Phase II clinical results, and we look forward to
the continual collaboration with external experts with the ultimate
goal of helping patients that are suffering from this devastating
condition.”
The Phase III clinical study is designed to
enroll patients worldwide, including countries such as the U.S.,
countries in Europe, and Australia. The multi-national, randomized,
double-blind, placebo-controlled trial has two arms: one arm
receiving vilobelimab (2400mg every other week) plus a low dose of
corticosteroids and another arm receiving placebo plus the same low
dose of corticosteroids. In both arms, corticosteroid treatment
will be initiated on day 1 and will be tapered off within the first
8 weeks of the trial. The primary endpoint of the study is complete
closure of the target ulcer at any time up to 26 weeks after
initiation of treatment.
The study has an adaptive trial design with an
interim analysis blinded for the sponsor and investigators (but
unblinded for the independent data safety monitoring committee),
which is planned upon enrollment of approximately 30 patients,
divided equally between the two aforementioned arms of the study.
The interim analysis with a set of predefined rules will take into
account the then-observed difference in complete target ulcer
closure between the two arms and will then determine whether the
trial sample size will be adapted or whether the trial should be
stopped due to futility. The enrollment period is projected to last
at least two years, and its overall period will depend on the total
trial size after sample size adaptation.
The Company has received Fast Track and Orphan
Drug (OD) designations by the U.S. Food and Drug Administration
(FDA), as well as OD designation by the European Medicines Agency
(EMA) for the treatment of PG.
About Pyoderma Gangrenosum
Ulcerative PG is a rare, non-infectious,
neutrophilic dermatosis recurrent skin disorder characterized by
painful, necrolytic, cutaneous ulcers that can rapidly progress. PG
is considered an autoimmune disease of the skin, but the underlying
cause of PG is not known in detail. PG lesions are histologically
characterized by pronounced infiltration of neutrophils, and
activated neutrophils surrounding the ulcers are believed to be
disease drivers. PG typically occurs in patients between the ages
of 40 and 60, and PG patients often also suffer from other
autoimmune disorders, such as inflammatory bowel disease and
rheumatoid arthritis. There are currently no approved drugs for the
treatment of PG in the U.S. or in Europe, and there is no
established standard of care based on controlled studies.
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.
Gohibic (vilobelimab) has been granted an Emergency Use
Authorization (EUA) in the U.S. 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). A Marketing Authorization Application (MAA) for
the treatment of adult patients with SARS-CoV-2 induced septic
acute respiratory distress syndrome receiving IMV or ECMO is
currently under review by the European Committee for Medicinal
Products for Human Use. In addition to development in COVID-19,
vilobelimab is being developed for other debilitating or
life-threatening inflammatory indications, including pyoderma
gangrenosum.
About InflaRx
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 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 EUA and in the future if approved for
commercial use in the United States or elsewhere; 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 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
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.
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