InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical
company pioneering anti-inflammatory therapeutics targeting the
complement system, today announced it will present preclinical data
on the company’s novel oral C5aR inhibitor, INF904, at the 2024
European Meeting on Complement in Human Diseases (EMCHD) being held
in Lübeck, Germany, September 2 – 6, 2024. In addition to two
poster presentations, InflaRx representatives will participate in a
C5a/C5aR-focused panel discussion as well as speak at a satellite
symposium.
EMCHD 2024 will focus on emerging developments
in the complement field with a goal of translating basic scientific
advancements into meaningful new therapeutic approaches to combat
human diseases. A preliminary conference program can be found here.
Given the company’s commitment to advancing science to treat
complement-mediated conditions, InflaRx is also one of the
corporate sponsors of this year’s meeting.
Poster Presentations
Poster title: INF904, a novel oral
C5a receptor 1 (C5aR1) antagonist, shows promising therapeutic
effects in inflammatory disease modelsPoster
number: P19Authors: Zhongli
Xu, Rui Liu, Ophelia Chen, Bruce P. Burnett, Maria Habel,
Renfeng Guo
Poster title: Preclinical
pharmacological characterization of INF904, an oral small molecule
antagonist to complement 5a receptor1 (C5aR1)Poster
number: P20Authors: Rui Liu, Zhongli Xu,
Ophelia Chen, Bruce P. Burnett, Maria Habel, Renfeng Guo
Other Sessions
Satellite symposium - oral
session: Inhibition of the C5a/C5aR1 axis in
inflammationSpeaker: Prof. Niels C. Riedemann,
Chief Executive Officer and Founder of
InflaRxDay/time: Monday, September 2, 3:00 – 3:30
pm CET
Satellite symposium - panel
discussion: Targeting C3 and/or C5 PathwaysInflaRx
participant: Prof. Niels C.
RiedemannDay/time: Monday, September 2, 4:00 –
5:00 pm CET
Lunch seminar: Complement C5a/C5aR
inhibition in human disease with best-in-class
inhibitorsInflaRx speakers: Prof. Niels C.
Riedemann, Chief Executive Officer and FounderDr. Renfeng Guo,
Chief Scientific Officer and Founder Dr. Camilla Chong, Chief
Medical OfficerDay/time: Tuesday, September 3,
1:00 – 1:45 pm CET
About INF904
INF904 is an orally administered, small molecule
inhibitor of the C5a receptor that has shown anti-inflammatory
therapeutic effects in several pre-clinical disease models.
Further, in contrast to the marketed C5aR inhibitor, in vitro
experiments demonstrated that INF904 has minimal inhibition of the
cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important
role in the metabolism of a variety of metabolites and drugs,
including glucocorticoids. Reported results from a first-in-human
study demonstrated that INF904 is well tolerated in treated
subjects and exhibits no safety signals of concern in single doses
ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg
once per day (QD) to 90 mg twice per day (BID) for 14 days.
Pharmacokinetic / pharmacodynamic data support best-in-class
potential of INF904 with a ≥90% blockade of C5a-induced neutrophil
activation achieved over the 14-day dosing period.
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 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 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.com.
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, our ability to successfully commercialize and the
receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19
patients by U.S. hospitals, our ability to positively influence
treatment recommendations by medical/healthcare institutes,
guideline bodies and other third-party organizations; 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 the EUA, and in
the future if approved for commercial use in the United States or
elsewhere; our ability to successfully implement The InflaRx
Commitment Program and estimate future write-downs due to expiry
and costs in the event of the price refunds, the success of our
future clinical trials for vilobelimab's treatment of COVID-19 and
other debilitating or life-threatening inflammatory indications,
including ARDS, 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 preclinical studies and
clinical trials of vilobelimab, INF904 and any other product
candidates, including for the development of vilobelimab in several
indications, including to treat PG, HS and CSU 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 and the receptiveness and approval by regulators
regarding the results of clinical trials and potential regulatory
approval or authorization pathways including related to our MAA
submission for vilobelimab and our BLA for GOHIBIC (vilobelimab);
the timing and outcome of any discussions or submission of filings
for regulatory approval or authorization of vilobelimab, INF904 or
any other product candidate, and the timing of and our ability to
obtain and maintain full regulatory approval or the EUA, of
vilobelimab or GOHIBIC (vilobelimab) for any indication; our
ability to leverage our proprietary anti-C5a and anti-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, INF904 and any other product
candidates, and the scope of such protection; whether the FDA, or
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; the success of our future clinical
trials for vilobelimab, INF904 and any other product candidates and
whether such clinical results will reflect results seen in
previously conducted preclinical studies and clinical trials; our
expectations regarding the size of the patient populations for, the
market opportunity for, the medical need for and clinical utility
of vilobelimab, INF904 or any other product candidates, if approved
or authorized for commercial use; 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
expectations regarding the scope of any approved indication for
vilobelimab; our ability to defend against liability claims
resulting from the testing of our product candidates in the clinic
or, if, approved or authorized, any commercial sales; if any of our
product candidates obtain regulatory approval or authorization, our
ability to comply with and satisfy ongoing drug regulatory
obligations and continued regulatory overview; our ability to
comply with enacted and future legislation in seeking marketing
approval or authorization 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 and other therapeutic products being developed in
similar medical conditions in which vilobelimab, INF904 or any
other of our product candidates is being developed 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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