InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, announced today interim results from the first
30 patients treated in the adaptive randomized Phase II/III trial
in patients with severe COVID-19 pneumonia.
The Phase II part of the study evaluated IFX-1
treatment plus best supportive care compared to best supportive
care alone for up to 28 days. Relative change (%) from baseline to
day 5 in oxygenation index (defined as PaO2/FiO2 ratio) was
assessed as the primary endpoint along with additional clinical
parameters until day 28. Relative change in the oxygenation index
at day 5 showed no differences between treatment groups. However,
IFX-1 treatment was associated with a lower 28-day all-cause
mortality when compared to the best supportive care group, along
with trends in disease improvement, as evidenced by fewer patients
experiencing renal impairment assessed by estimated glomerular
filtration rates, more patients showing reversal of blood
lymphocytopenia and a greater lowering of lactate dehydrogenase
concentrations. In IFX-1-treated patients, pulmonary
embolisms reported as serious adverse events were lower compared to
the best supportive care arm. Also, a temporary increase of D-dimer
levels, as potential expression of induction of blood clot lysis,
was detected in the first days after initiation of IFX-1 treatment.
The data are being prepared for submission to a scientific
journal1.
Dr. Korinna Pilz, Global Head of Clinical
R&D at InflaRx, commented: “These are encouraging preliminary
data which suggest that C5a inhibition might be beneficial in
treating critically ill COVID-19 patients.”
A total of 30 patients were randomized in the
trial, and 15 patients were treated in each arm: IFX-1 plus best
supportive care or best supportive care alone. Over a treatment
period of 28 days, patients in the IFX-1 arm received a maximum of
seven doses of 800 mg IFX-1 intravenously on separate days. At
randomization, 18 patients were intubated (60%), and 12 patients
(40%) had other oxygen supply. A higher number of patients with 2
or more comorbidities associated with increased COVID-19 mortality
were reported in the IFX-1 treatment group compared to best
supportive care group. Twenty-eight-day all-cause mortality in the
IFX-1 treatment group was 13% (2 out of 15) versus 27% (4 out of
15) in the control group. In the best supportive care group, four
patients died of COVID-19-induced multi-organ failure, and three of
them had pulmonary embolisms reported as a serious adverse event.
In the IFX-1 arm, one patient died after an acute ventilator tube
complication (leakage) and one patient with a history of severe
chronic obstructive pulmonary disease died of pulmonary
failure.
Prof. Niels Riedemann, CEO and co-founder of
InflaRx, commented: “InflaRx’s core expertise in the acute care
field and our development work with IFX-1 in sepsis and viral lung
injury put InflaRx in a scientifically strong position to develop
IFX-1 in COVID-19. We are encouraged by these preliminary
data.”
Serious adverse event (SAE) rates were
comparable between groups, but the rate of pulmonary embolisms
reported as SAEs was substantially lower in the IFX-1 treatment
group. Upon review of the safety data, the independent data safety
monitoring board recommended continuation of the trial into the
Phase III part.
This Phase II part of the trial was exploratory
in nature and was not powered to show statistically significant
differences in clinical endpoints. Relative change (%) from
baseline to day 5 in the oxygenation index, chosen as the primary
endpoint for the Phase II part, showed a large variability and
dependency on patient positioning and intubation status which
excludes this endpoint from being used in a confirmatory study.
InflaRx is now evaluating continuing the study
in an adequately powered, placebo-controlled, double blinded, Phase
III part using 28-day all-cause mortality as the primary endpoint,
an accepted regulatory primary endpoint for critical care
studies.
About IFX-1:
IFX-1 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, IFX-1 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. IFX-1 has been demonstrated to control the
inflammatory response driven tissue and organ damage by
specifically blocking C5a as a key “amplifier” of this response in
pre-clinical studies. IFX-1 is believed to be the first monoclonal
anti-C5a antibody introduced into clinical development.
Approximately 300 people have been treated with IFX-1 in clinical
trials, and the antibody has been shown to be well tolerated. IFX-1
is currently being developed for various indications, including
Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma
Gangraenosum and COVID-19 pneumonia.
About InflaRx N.V.:
InflaRx (Nasdaq: IFRX) is a clinical-stage
biopharmaceutical company focused on applying its proprietary
anti-C5a technology to discover and develop first-in-class, potent
and specific inhibitors of C5a. Complement C5a is a powerful
inflammatory mediator 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 –
Global Head of Business Development & Corporate StrategyEmail:
jordan.zwick[at]inflarx.deTel: +1 917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas Jungfer Email: inflarx[at]mc-services.eu
Europe: +49 89-210 2280 US: +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,” “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 ongoing and planned preclinical development and
clinical trials, including a potential continuation into a Phase
III part trial in patients with severe COVID-19 pneumonia; 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; 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.
___________________1 Data and trends reflect the
knowledge at the time of the press release, with ongoing data
cleaning not fully completed. Data will be submitted for
publication upon completion of data cleaning activities.
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