InflaRx N.V. (Nasdaq: IFRX), a biotechnology company
pioneering anti-inflammatory therapeutics targeting the complement
system, announced today topline results from the multiple ascending
dose (MAD) part of its randomized, double-blind, placebo-controlled
Phase I trial for INF904, an orally administered low molecular
weight C5aR inhibitor. The pharmacokinetic (PK) and pharmacodynamic
(PD) parameters confirm the favorable data InflaRx reported
recently from the single ascending dose (SAD) part of the study,
which provides support for the best-in-class potential of this drug
candidate. INF904 was well tolerated and there were no adverse
safety events of concern after repeated dosing in participants over
the entire tested dose range.
In the MAD part of the randomized, double-blind,
placebo-controlled Phase I trial, 24 participants received multiple
doses of INF904 for 14 days of either 30 mg once per day (QD), 30
mg twice per day (BID) or 90 mg BID. The study’s primary objective
was to evaluate the safety and tolerability of repeated dosing.
Several PK parameters were analyzed as secondary endpoints, and the
effect of the dosing scheme on C5a-induced neutrophil activation in
blood samples from the participants was also explored in an ex vivo
assay.
“We are very pleased that the MAD part of the
Phase I study exceeded the already compelling results from the SAD
part of the study. The PK and PD profiles suggest that INF904
allows for highly effective inhibition of the C5a/C5aR pathway and
that INF904 should enable consistent control of C5aR signaling in
patients. In addition, we have the potential to apply a broad dose
range up to high doses for the planned development of INF904 in
chronic immune-inflammatory conditions,” said Camilla Chong, MD,
Chief Medical Officer of InflaRx. “We are excited to advance this
highly promising oral C5aR inhibitor into Phase II clinical
development.”
The safety analysis of INF904 in the MAD part of
the Phase I study demonstrated that it was well tolerated in
participants over the entire dose range and resulted in no safety
signals of concern. The overall percentage of adverse events (AEs)
in INF904 treated participants was 77.8%, which was lower than the
83.3% observed in the placebo group. There were no serious or
severe AEs observed at any dosing level.
Analysis of the PK profile showed that potential
target AUC0-12h, Cmax, and trough values were achieved rapidly
within 14 days of 30 mg BID dosing. INF904 exposure further
increased proportionally with dosing up to 90 mg BID. These results
were demonstrated even when participants ingested the drug in a
fasted state, suggesting that food is not required to achieve
potentially therapeutic drug levels.
Analysis of the PD profile showed that the
blocking activity of C5a-induced neutrophil activation by INF904
reached equal to or above 90% over the 14-day dosing period for all
tested doses in an ex vivo challenge assay where physiological and
disease-relevant levels of C5a were added to blood samples provided
by the trial participants.
InflaRx previously reported the data from the
SAD part of the trial with 62 healthy volunteers in a press release
and conference call. The SAD part showed a favorable
dose-proportional systemic exposure with desired blocking activity
(>90%) of C5a-induced neutrophil activation at disease-relevant
C5a levels for doses of 30 mg to 240 mg 24 hours
post-administration.
In parallel, InflaRx has progressed with the
development of a commercially viable formulation of INF904 which
the Company plans to introduce into Phase II development towards
the end of 2024.
InflaRx is currently conducting additional
required pre-clinical studies, including long-term chronic
toxicology studies, to enable longer-term dosing of INF904 for
chronic inflammatory diseases. InflaRx currently plans to initiate
a short-term dosing Phase II study towards the end of 2024,
followed by a longer-term dosing Phase II study in 2025. Further
details of this clinical development plan with selection of
indications will be announced in due course.
Conference call scheduled for today, January 4,
2024
InflaRx will host a conference call today,
January 4, 2024 at 8:30 a.m. EST (14:30 CET) to provide more
details about the announced topline results of the MAD 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.
InflaRx’s management team will host
investor and business meetings during JPM Week from January 8 to
11, 2024 in San Francisco, California.
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. 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. InflaRx plans to bring INF904 into clinical Phase II
development towards the end of 2024.
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 Emergency Use Authorization 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 pyoderma gangrenosum, 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 U.S. Food and
Drug Administration, 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
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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