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 OfficerEmail:
IR@inflarx.deTel: +1 917-338-6523
MC Services AG
Katja Arnold, Laurie Doyle, Andreas
JungferEmail: inflarx@mc-services.euEurope: +49 89-210 2280US:
+1-339-832-0752
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