InflaRx Announces Presentation of New C5a and Vilobelimab (IFX-1) Data from Phase IIB SHINE Study at the 2021 Virtual Europea...
February 11 2021 - 7:30AM
InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, today announced the presentation of new data
with vilobelimab (IFX-1), a first-in-class anti-C5a antibody,
demonstrating significantly elevated baseline C5a levels in
moderate and severe Hurley Stage II and III hidradenitis
suppurativa (HS) patients compared to healthy volunteers. Data will
be presented at the 10th Conference of the European Hidradenitis
Suppurativa Foundation e.V. (EHSF) by Prof. Giamarellos-Bourboulis,
from the ATTIKON University, Athens, Greece. The presentation,
entitled, Complement split product C5a is elevated in moderate and
severe hidradenitis suppurativa: clinical improvement by targeted
therapy coming from the SHINE Study, will take place on February
11, 2021 at 11:30 am EST (5:30 pm CET).
The presentation will highlight the following
content:
- C5a
levels were significantly elevated in HS patients compared to
healthy volunteers. C5a levels from the study were
measured using a validated enzyme immunosorbent assay. Plasma was
sampled from all patients before randomization and repeated at week
16. Median C5a (Q1/Q3) was 60.95 ng/ml (39.11/97.87) and 61.21
ng/ml (42.74/84.95) in Hurley stage II and III patients,
respectively. In 20 healthy volunteers, C5a was 26.75 ng/ml
(18.80/44.27).
- Elevated
C5a levels in HS patients were dose-dependently suppressed by
vilobelimab, and, within the high-dose treatment group
(1200 mg q2w), suppressed to levels below normal median C5a levels
of healthy humans at day 4 and week 16 upon initiation of
treatment.
-
Additional baseline characteristics are being
disclosed. Overall, 98 patients were classified as Hurley
stage II and 79 as Hurley stage III. Differences of interest
include the median AN count levels at baseline (9.5 for the placebo
group and 12.5 for the vilobelimab highest dose group).
These findings confirm earlier reported results
on elevated C5a levels in HS patients and on the ability of
vilobelimab to reduce such levels in HS patients. Together with the
previously reported data on vilobelimab´s ability to reduce
inflammatory lesions and scores, these data further stress the
potential important role played by C5a in the pathogenesis of HS.
The results support the company´s plan to continue development of
vilobelimab in HS.
About Hidradenitis Suppurativa
(HS):
HS is a chronic debilitating systemic skin
disease which results in painful inflammation of the hair
follicles, typically in the armpit, groin and genitalia regions. HS
patients suffer primarily from pain driven by inflamed nodules and
abscess formation and significant discomfort resulting from the
constant formation of pus, particularly in the areas described
above, leading to social isolation. HS is typically present after
adolescence and often develops into a life-long debilitating
chronic disease. In the United States, up to 200,000 patients are
affected annually with moderate to severe disease (Hurley stages II
to III), with a current increase in recognition and diagnoses being
expected and discussed amongst key opinion leaders. In Europe, the
number of affected patients is considered to be higher, with a
trend of more cases of HS in countries with overall warmer
climates. The standard of care for HS patients includes antibiotic
treatment, which often only provides temporary symptomatic relief.
In some cases, patients also undergo surgery. The only approved
biological drug in this indication for moderate to severe HS
patients is an anti-TNF-alpha monoclonal antibody.
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,
cancer and severe COVID-19.
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 – Chief Strategy OfficerEmail:
jordan.zwick@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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