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InflaRx Completes Enrollment in Vilobelimab (IFX-1) European Phase II Study in ANCA-associated Vasculitis

Tue 5th January, 2021 12:30pm
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JENA, Germany, Jan. 05, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a
clinical-stage biopharmaceutical company developing anti-inflammatory
therapeutics by targeting the complement system, announced today the European
phase II IXCHANGE study of vilobelimab (IFX-1), a first-in-class anti-C5a
antibody, in ANCA-associated vasculitis (AAV) has completed enrollment.

“We are pleased to have met our enrollment goal in the vilobelimab European
phase II trial in AAV,” said Dr. Korinna Pilz, Global Head of Clinical
Research and Development of InflaRx. “ANCA-associated vasculitis is a rare
but recurring and life-threatening disease for which new treatment options are
urgently needed. Given the suggested important role of the C5a signaling
pathway, especially for the life-threatening flare phases in this disease, we
believe that vilobelimab could be a promising therapeutic option and look
forward to seeing the results from this trial and the US safety trial later
this year.”

The randomized, double-blind, placebo-controlled phase II study enrolled 57
patients with AAV throughout Europe. The main objective of the study is to
evaluate the safety and efficacy of vilobelimab in AAV. The study is being
conducted in two parts. Part 1 compares vilobelimab plus a reduced dose of
glucocorticoids versus a standard dose of glucocorticoids, while part 2
compares vilobelimab alone versus a standard dose of glucocorticoids. All
patients receive standard of care immunosuppressive therapy (rituximab or
cyclophosphamide). Each part of the study has a sixteen-week treatment period
with an eight-week observational period. The primary efficacy endpoint of the
study is the proportion of patients achieving a clinical response defined as a
50% reduction in Birmingham Vasculitis Activity Score (BVAS) at week 16
compared to baseline, a well-established endpoint that has been used in
previous AAV studies. Secondary endpoints include clinical remission,
evaluation of the Vasculitis Damage Index, reduction of glucocorticoid
toxicity, several relevant other parameters such as glomerular filtration rate
and patient reported outcomes. Part 1 of the study enrolled 30 patients while
part 2 enrolled an additional 27 patients. Final results are expected by the
end of 2021.

Vilobelimab is also being studied in a randomized, double-blind,
placebo-controlled US phase II IXPLORE study in patients with AAV. The study
compares two different dose regimens of vilobelimab to placebo. All patients
receive current standard of care immunosuppressive therapy and high dose
glucocorticoids. The main objective of the IXPLORE study is to evaluate the
safety of vilobelimab, as this is the first time the drug is being
administered to patients with AAV in the US. Efficacy endpoints include
response rate based on BVAS and other, similar efficacy endpoints used in the
European study. The study also has a sixteen-week treatment period with an
eight-week observational period. All 19 patients enrolled have completed the
study. Final results are expected by mid-2021.

AAV is a rare and life-threatening autoimmune disease in which activation of
the complement system, and specifically the generation of larger amounts of
C5a, is believed to play a key role in the neutrophil-driven vessel
inflammation that defines the disease. AAV affects approximately 40,000 and
75,000 patients in the United States and Europe, respectively.

About vilobelimab (IFX-1):

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 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.
Vilobelimab is believed to be the first monoclonal anti-C5a antibody
introduced into clinical development. Approximately 300 people have been
treated with vilobelimab in clinical trials, and the antibody has been shown
to be well tolerated. Vilobelimab is currently being developed for various
indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis,
Pyoderma Gangraenosum and severe COVID19.

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


InflaRx N.V.
Jordan Zwick – Chief Strategy Officer
Tel: +1 917-338-6523

MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer
Europe: +49 89-210 2280
US: +1-339-832-0752


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,”
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and planned pre-clinical development and clinical trials; 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.


GlobeNewswire, Inc. 2021
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