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InflaRx Completes Enrollment of Vilobelimab Phase IIa Study in Pyoderma Gangraenosum

Thu 15th April, 2021 12:30pm
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* Target enrollment of 18 patients reached across three different dose groups

* Interim results will be available by the end of 2021 with final results
expected in 2022
* Initial positive data from the first 5 patients previously announced in Q1
2020
JENA, Germany, April 15, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX),
a clinical-stage biopharmaceutical company developing anti-inflammatory
therapeutics by targeting the complement system, announced today the
achievement of target enrollment of the Phase IIa open label study of
vilobelimab in patients with Pyoderma Gangraenosum (PG).

Dr. Korinna Pilz, Global Head of Clinical Research and Development of InflaRx,
commented: “The full enrollment of our PG study is a significant milestone
for the clinical development of vilobelimab as we continue to build the
evidence that C5a is an important target for neutrophil-driven skin diseases.
PG is a devastating autoimmune disease, and we hope our program can play a
vital role in helping these patients.”

This open-label Phase IIa proof-of-concept study has reached the target
enrollment goal of 18 patients with moderate to severe PG at sites in the US,
Canada and Europe. Patients in three different ascending dose groups are being
treated with vilobelimab for 27 weeks with a two-month follow-up period. The
main objectives of the study are the evaluation of the safety and efficacy of
vilobelimab in patients with PG. Efficacy will be evaluated by (i) a responder
rate defined as Physician Global Assessment ≤3 of the target ulcer at
various timepoints and (ii) time to complete closure of the target ulcer. Both
endpoints will be compared with historical data. Additional clinical endpoints
include a photographic documentation and analysis of the ulcer size and
several patient-reported outcome parameters, such as pain score and
Dermatology Life Quality Index (DLQI).

In 2020, InflaRx announced positive initial data from the first five patients
in the lowest dose group. Of these five initial patients, two patients
achieved complete closure of the target ulcer and complete healing of all
other PG ulcers. The drug was well tolerated and no drug-related severe
adverse events (SAEs) have been recorded to date in the study.

A second interim analysis, including six patients treated in the second dose
group until day 99, will be available by the end of 2021. Final results from
all patients, including the highest dose group, are expected in 2022.

For more information about the study, visit www.clinicaltrials.gov
(NCT03971643).

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 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, cutaneous squamous cell carcinoma and severe COVID-19.

About pyoderma gangraenosum (PG):

PG is a rare and debilitating neutrophil-driven, autoinflammatory skin disease
characterized by an acute, destructive ulcerating process of the skin,
primarily occurring on the legs but also other regions of the body. It occurs
in people in their 40s and 50s. The exact prevalence of PG is not yet known,
but it is estimated that up to 50,000 people in the US and Europe are affected
by this disease. Many PG patients also suffer from other autoimmune disorders,
including inflammatory bowel diseases like ulcerative colitis, arthritides
like rheumatoid arthritis, and hematological diseases such as multiple
myeloma.

Patients suffer from severe pain, long healing times, and frequent relapses.
There are currently no FDA approved drugs for the treatment of PG. Current
treatment options include the use of systemic immunosuppression in rapidly
progressing cases.

C5a is a key factor for neutrophil tissue infiltration and neutrophil
activation, which are believed to play an important amplifying role in PG.
Thus, C5a inhibition may be able to prevent neutrophil infiltration and
activation in PG patients. Given the detected activity of C5a inhibition by
vilobelimab in another neutrophil-driven skin disorder, hidradenitis
suppurativa, InflaRx is currently conducting a Phase IIa clinical study to
investigate the potential benefit of vilobelimab for patients suffering from
PG.

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.de.

Contacts:

InflaRx N.V.

Jordan Zwick – Chief Strategy Officer
Email: IR@inflarx.de
Tel: +1 917-338-6523

MC Services AG

Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: inflarx@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; 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.

 

(https://www.globenewswire.com/NewsRoom/AttachmentNg/b865827c-d3ff-479b-90ea-5284ef1a1a8c)



GlobeNewswire, Inc. 2021
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