InflaRx Announces Decision to Enter Phase III Development of IFX-1 in Severe COVID-19 Induced Pneumonia
July 21 2020 - 7:30AM
InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, announced today that the Company has decided to
continue development with IFX-1 in severe COVID-19 induced
pneumonia. The Company plans to initiate a double-blinded,
randomized, placebo-controlled Phase III trial that will be
adequately powered for statistical analyses.
In the Phase III part of the study, subject to
regulatory approval, the Company plans to enroll approximately 360
early intubated, critically ill patients with COVID-19 induced
pneumonia. InflaRx plans to conduct the study at sites in the US,
Europe, South America and potentially other regions. An interim
analysis is currently planned after enrollment of 180 patients,
with the potential for an early stop for efficacy or futility. In
addition to the primary endpoint of 28-day all-cause mortality,
other planned key endpoints include assessments of organ support
and assessment of disease improvement on the ordinal
scale.
Dr. Korinna Pilz, Global Head of Clinical
R&D at InflaRx, noted: “Data from the initial exploratory Phase
II part of the study in patients with severe COVID-19 induced
pneumonia suggested a positive impact of IFX-1 treatment on the
all-cause mortality rate and other endpoints. Based on these
encouraging results, we are excited to initiate the Phase III part
of the trial, which we anticipate starting in the coming
months.”
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. The Phase II part was randomized and
enrolled a total of 30 patients. The 28-day all-cause mortality
rate was 13% (n = 2 out of 15) in the IFX-1 treatment arm compared
to 27% (n = 4 out of 15) in the best supportive care arm. All
deaths in the best supportive care arm occurred in COVID-19 induced
multi-organ failure. In the IFX-1 treatment arm, one patient died
after an acute ventilator tube complication (leakage) leading to
hypoxia and one patient who met an exclusion criterion with a
history of severe chronic obstructive pulmonary disease, which was
not known at time point of enrollment, died of pulmonary failure.
In the IFX‑1 treatment arm fewer patients experienced renal
impairment assessed by estimated glomerular filtration rates and
more patients showed reversal of blood lymphocytopenia and a
greater lowering of lactate dehydrogenase concentrations as a sign
of reduction in tissue damage. A temporary, but statistically
significant increase of D-dimer levels in the first days following
IFX-1 administration was noted, as a potential signal for induction
of blood clot lysis. No statistically significant group differences
on the chosen primary endpoint of relative change (%) from baseline
to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were
detected.
The Phase II results have been submitted for
publication to a peer-reviewed medical journal along with a
preprint server.
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 induced 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 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 ongoing and planned preclinical
development and clinical trials, including the planned 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
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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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