InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, announced today that the Phase III part of the
Phase II/III PANAMO study with mechanically ventilated COVID-19
patients showed a relative reduction in 28-day all-cause mortality
of 23.9% (vilobelimab 31.7% versus placebo 41.6%, p=0.094), which
was not statistically significant using site-stratified Cox
regression analysis as pre-specified in the final statistical
analysis plan of the study. All patients in the study received
standard of care.
At the recommendation of regulatory authorities,
during the course of the trial, the Company changed the statistical
analysis method for the primary endpoint. The original protocol
specified a non-stratified Cox regression analysis, and the final
statistical analysis plan specified a site-stratified analysis
intended to account for the site stratification of patients at
randomization. The original protocol specified analysis would have
resulted in a p-value of 0.027 (statistically significant).
Additionally, logistic regression analyses of the 28-day mortality
resulted in p-values of <0.05 for 3 out of the 4 pre-specified
analyses. These analyses and other results will be discussed in
more detail on today’s conference call.
A pre-specified analysis of patients from
Western European countries (n=209) showed a relative reduction in
28-day all-cause mortality of 43% (vilobelimab 21.2% versus placebo
37.2%, hazard ratio: 0.5, p=0.014), suggesting an improvement in
mortality in line with the reported Phase II data of the PANAMO
Phase II/III study.
Prof. Niels C. Riedemann, CEO and Founder of
InflaRx, commented: “The successful conduct of this study was only
possible through the support of many involved parties, among them
our patients and their loved ones, our dedicated investigators,
including principal investigator Prof. Alexander Vlaar from the
Amsterdam University Medical Center, and our team members. We want
to express our sincere gratitude to all of these involved
individuals. As we have all seen, severe COVID-19 is an extremely
complex, difficult-to-treat disease which continues to take lives
in the most severely affected patients. Although the study results
in the pre-specified primary outcome analysis were not
statistically significant, we believe that data from the study
suggest that vilobelimab treatment resulted in a robust signal for
survival improvement when compared to placebo, particularly in
those patients from Western Europe and those with higher baseline
severity. Especially encouraging is the fact that the analysis of
patients treated in Europe is in line with the published Phase II
results of the PANAMO study. We plan to discuss the data with
regulatory authorities to determine potential next steps in the
development of vilobelimab for this indication.”
Three pre-specified subgroup analyses assessed
the treatment effect of vilobelimab in patients with higher
baseline disease severity. These analyses all showed a signal
towards a reduction in 28-day all-cause mortality in the
vilobelimab arm compared to the placebo arm in intubated patients
suffering from one or more additional organ support captured as
baseline ordinal scale of 7 (n=237, p=0.028); in patients with
severe acute respiratory distress syndrome (ARDS) and PaO2/FiO2
<100 (n=98, p=0.044); and in patients with kidney impairment,
captured by estimated glomerular filtration rate (eGFR) of <60
mL/min/1.73m² (n=108, p=0.036).
Sixty-day all-cause mortality, a key secondary
endpoint, showed a continued reduction of mortality in the
vilobelimab arm (36.5% vilobelimab versus 47.2% placebo; p=0.082,
applying the site-stratified Cox regression analysis as
pre-specified in the final statistical analysis plan, and p=0.016,
applying the originally planned non-stratified Cox regression
analysis).
The randomized, double-blind, placebo-controlled
Phase III part of the PANAMO Phase II/III study randomized 369
mechanically ventilated patients with COVID-19 across sites in the
EU, South America and other regions. Patients were randomized 1:1
to receive either vilobelimab or placebo; both groups received
standard of care, including steroids. The primary endpoint was
28-day all-cause mortality; secondary endpoints included 60-day
all-cause mortality as well as assessment of organ support and
disease improvement on the ordinal scale.
In this study, vilobelimab appeared to be safe
and well-tolerated. Frequency and quality of adverse events (AEs)
and serious adverse events (SAEs) were comparable between treatment
arms.
Approximately 97% of patients received
concomitant corticosteroids and 98% received concomitant
anticoagulation treatment.
InflaRx intends to publish detailed results from
this study in a peer-reviewed journal and present the findings at a
medical meeting in the coming months. The Company plans to discuss
data from the PANAMO study with regulatory authorities in due
course.
The work described herein was partly funded by
the German Federal Government through grant number 16LW0113
(Vilo-Covid). All responsibility for the content of this work lies
with InflaRx.
Conference call scheduled for today at
8:30 am EDT/2:30 pm CET
InflaRx will host a conference call to discuss
the Phase III PANAMO study results today, Thursday, March 31st at
8:30 am EDT (2:30 pm CEST). 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 of the event will be available on the InflaRx website in the
Investors - Events & Presentations section.
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, which is not the
case for molecules blocking the cleavage of C5. Vilobelimab has
been demonstrated in pre-clinical studies to control the
inflammatory response driven tissue and organ damage by
specifically blocking C5a as a key “amplifier” of this response.
Vilobelimab is believed to be the first monoclonal anti-C5a
antibody introduced into clinical development. Over 300 people have
been treated with vilobelimab in completed clinical trials, and the
antibody has been shown to be well tolerated. Vilobelimab is
currently being developed for various indications, including
hidradenitis suppurativa, and has recently reported positive Phase
II results in ANCA-associated vasculitis and Phase IIa results in
pyoderma gangrenosum. Vilobelimab is also in Phase II development
for patients suffering from cutaneous squamous cell carcinoma
(cSCC).
About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a clinical-stage
biopharmaceutical company focused on applying its proprietary
technology to discover and develop first-in-class or best-in-class,
potent and specific inhibitors of C5a and C5aR. Complement C5a and
C5aR are powerful inflammatory mediators involved in the
progression of a wide variety of autoimmune and other inflammatory
diseases. 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.Jordan Zwick –
Chief Strategy OfficerEmail: IR@inflarx.deTel: +1 917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas JungferEmail: inflarx@mc-services.euEurope:
+49 89-210 2280US: +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,” “believe,” “estimate,”
“predict,” “potential” or “continue” and similar expressions.
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 development of vilobelimab for
mechanically ventilated COVID-19 patients, future analysis of our
Phase II/III PANAMO trial and interactions with regulators
regarding the results of the trial and potential regulatory
approval pathways; the impact of the COVID-19 pandemic on the
Company; the timing and our ability to commence and conduct
clinical trials; potential results from current or potential future
collaborations; our ability to make regulatory filings, obtain
positive guidance from regulators, and obtain and maintain
regulatory approvals for our product candidates; our intellectual
property position; our ability to develop commercial functions;
expectations regarding clinical trial data; decisions regarding the
strategic direction of the Company; our results of operations, cash
needs, financial condition, liquidity, prospects, future
transactions, growth and strategies; the industry in which we
operate; the trends that may affect the industry or us and the
risks, uncertainties and other factors described under the heading
“Risk Factors” in InflaRx’s periodic filings with the 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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