InflaRx N.V. (Nasdaq: IFRX), a biotechnology company
pioneering anti-inflammatory therapeutics targeting the complement
system, announced today its topline results from the single
ascending dose (SAD) part of its randomized, double-blind,
placebo-controlled Phase I trial of the orally administered, low
molecular weight C5aR inhibitor INF904. In the SAD part of the
study, INF904 demonstrated an excellent safety and tolerability
profile as well as a very favorable pharmacokinetic (PK) and
pharmacodynamic (PD) profile, confirming INF904´s best-in-class
potential.
The SAD part of the Phase I first-in-human trial
enrolled 62 healthy volunteers within six different dosing groups
from 3 mg to 240 mg who were randomly assigned to receive INF904 or
a placebo. Different drug concentrations were tested for the 60 mg
dosing group. The main objectives were to assess safety and
tolerability of single ascending doses under fasting conditions.
Secondary endpoints included several PK parameters, and the effect
of INF904 on C5a-induced neutrophil activation in blood samples
from treated volunteers ex vivo also was explored.
“Our team has spent several years developing an
orally administered inhibitor of the terminal complement C5a / C5aR
pathway with optimized PD and PK properties primarily for the
long-term treatment of patients with chronic inflammatory
conditions in need of improved therapeutic options. We are very
pleased that the results announced today confirm our pre-clinical
studies with INF904, which did not reveal any safety concerns and
demonstrated favorable PK and PD profiles. We look forward to
seeing the results from the MAD part of the study and advancing
INF904 in development,” commented Renfeng Guo, M.D., Chief
Scientific Officer and Founder of InflaRx.
The results show that INF904 was well tolerated
in treated patients and resulted in no safety signals of concern in
single doses ranging from 3 mg to 240 mg. The overall percentage of
adverse events (AEs) was lower in the INF904 treated patients
compared to the placebo group, and no serious or severe AEs were
observed at any dosing level. No related AEs were reported in
conjunction with INF904 dosing.
Analysis of INF904 PK in subject plasma samples
revealed sustained exposure to INF904 with six hours to maximum
concentration (tmax). INF904 plasma levels were dose proportional
for systemic exposure (AUClast) and nearly dose proportional for
maximum concentration (Cmax) over the dose range used in the study.
With the 30 mg dose, INF904 reached a Cmax of 289 ng/ml with an
AUClast of 5197 h.ng/ml, which are approximately 3-fold and
10-fold, respectively, higher than the published Phase I data from
the only marketed comparator1.
Single doses of 30 mg or higher of INF904
achieved ≥90% blocking of C5a induced up-regulation of the
activation marker CD11b on neutrophils in plasma samples from
subjects ex vivo at 24 hours post dosing. This inhibition was
achieved when 12.6 nM recombinant C5a was added as stimulus in this
assay, a C5a concentration which can be observed in patients with
severe inflammatory conditions such as the immuno-dermatological
disease, hidradenitis suppurativa, or during life-threatening
inflammation (e.g., in critically ill COVID-19 patients or septic
patients). Thus, INF904 inhibition of C5a-induced neutrophil
activation in human plasma achieved the set goal for effective C5aR
control at disease relevant C5a levels.
“We are excited about the results we have seen
to date in this Phase 1 trial, which support the best-in-class
potential of our orally administered C5aR inhibitor INF904,” said
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of
InflaRx. “Based on these promising results, we are initiating
necessary steps to prepare for the future clinical evaluation of
INF904. We plan to develop INF904 primarily for
complement-mediated, chronic autoimmune and inflammatory diseases
where oral administration is the preferred choice for patients,” he
added.
The MAD part of the Phase 1 trial is ongoing,
and the Company expects to present results from the approximately
24 healthy volunteers at the beginning of 2024. InflaRx is
currently preparing to initiate additional required pre-clinical
studies, including chronic toxicology studies, for the future
clinical development of INF904 in chronic inflammatory diseases. In
parallel, the Company is evaluating select potential indications
for future development.
Conference call scheduled for today, September
11, 2023
InflaRx will host a conference call today,
September 11, 2023 at 8:30 am EDT (14:30 CEST) to provide more
details about the announced topline results of the SAD part of its
Phase I study of INF904 in healthy human subjects. To participate
in the conference call, participants may pre-register here and will
receive a dedicated link and dial-in details to easily and quickly
access the call. A replay will be available on the InflaRx website
in the Investors – Events & Presentations section after the
live conference call has concluded.
About INF904
INF904 is an orally administered small molecule
inhibitor of C5a-induced signaling via the receptor C5aR. INF904
showed anti-inflammatory therapeutic effects in several
pre-clinical disease models, and there were no obvious
toxicological findings in investigational new drug (IND)-enabling
studies, including required good laboratory practice (GLP) toxicity
analyses. Oral INF904 showed higher plasma exposure in animals,
including non-human primates, and improved neutrophil-inhibitory
activity in a hamster model compared to a marketed C5aR inhibitor.
Further, in contrast to the marketed C5aR inhibitor, in vitro
experiments demonstrated that INF904 has substantially less
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 the single ascending dose part of an ongoing first-in-humans
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. InflaRx plans to study INF904 for the
treatment of complement-mediated, chronic autoimmune and
inflammatory diseases where oral administration is the preferred
choice for patients.
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 first-in-class, 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, our ability to 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 emergency use authorization (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 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, including
the MAD part of the Phase 1 trial with C5aR inhibitor INF904, 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 (MAA) submission
for vilobelimab and our biologics license application (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 U.S. Food and Drug
Administration (FDA), the European Medicines Agency (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 (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.
______________________1 InflaRx has not
conducted a head-to-head comparison of the marketed C5aR inhibitor
to INF904 in a clinical study. Without such head-to-head data,
InflaRx is unable to make comparative claims between INF904 and the
marketed C5aR inhibitor.
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