Full Press Release Details
InflaRx Announces Presentation of New Clinical
Lead Candidate IFX-1 in Hidradenitis Suppurativa
Germany and NEW YORK Feb. 6, 2019 (Globe Newswire) - InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing
innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the
innate immune system, today announced that new clinical data with IFX-1, a first-in-class anti-human complement factor C5a antibody,
in patients with moderate to severe Hidradenitis Suppurativa (HS) are to be presented this week at the 8th Conference
of the European Hidradenitis Suppurativa Foundation in Wroc aw, Poland. HS is a painful and debilitating chronic inflammatory
skin disease with limited treatment options.
long-term data from phase IIa trial:
reported, an open-label phase IIa clinical trial in 12 patients with severe HS showed a response of 75% according to HS Clinical
Response (HiSCR) criteria at the end of an 8-week treatment period and 83% at the end of a 12-week treatment-free follow-up period.
The results to be reported on February 8th are from an additional retrospective evaluation of the long-term effect
of IFX-1post treatment. Ten of the 12 patients were available for this analysis. The median observation period after the last
IFX-1 treatment was 226 days (range 119 to 324 days). The long-term efficacy was assessed by the abscess and inflammatory nodule
count (AN count), number of draining fistulas, HiSCR assessment, and the occurrence of flares. Flares were defined as deterioration
of HS requiring antibiotic therapy.
occurred during the treatment period, and two flares occurred during the scheduled follow-up period. In the long-term follow-up,
there were 26 flares, ranging from two to four per patient. The median time to the first flare after stopping IFX-1 treatment
was 209 days (range 54 to 318 days), while off of medication, 50% of patients had no flares to day 203.
of AN count, number of draining fistulas, and HiSCR supported the assumption of the long-lasting effect of IFX-1 after stopping
med. Evangelos J. Giamarellos-Bourboulis, ATTIKON University Hospital in Athens, Greece, the principal investigator of this trial,
commenting on the IFX-1 data, said: "It is gratifying
to see that sustained remission was observed in most patients treated with IFX-1. It is notable that after only 8 weeks of treatment,
the median time to the first flare was almost seven months. With limited options for Hidradenitis Suppurativa, there is a major
need to find more effective therapies that can provide relief over an extended period of time. I look forward to seeing the results
from the ongoing randomized study with IFX-1 in this indication, which should give us additional insight into the efficacy and
safety of this novel treatment for this debilitating condition."
characteristics from ongoing phase IIb trial:
Dr. Giamarellos-Bourboulis
is also to present the blinded baseline characteristics from an ongoing prospective, randomized, multicenter, double-blind, placebo-controlled
phase IIb trial evaluating IFX-1 in patients with moderate to severe HS. The primary objective of the trial is to evaluate a dose
response signal of IFX-1 with HiSCR at week 16. InflaRx announced completion of enrollment in November 2018. A blinded snapshot
of the clinical database was performed, and available data from 179 patients at baseline are being reported. 56% of the patients
are female, and 44% are male, with a mean age of 37.1 years old, and mean body weight of 92.2 kg. The median duration of HS was
8 years (range 1 to 39 years); while 59% and 41% of patients were classified as Hurley Stage 2 or 3, respectively. The median
inflammatory nodule count at baseline was 9 (range 3 to 58). These baseline demographical data and characteristics are in-line
with the overall moderate to severe HS population, and similar to that of other clinical studies in this field.
from the phase IIb study are expected during the second quarter of 2019.
M.D., Chief Medical Officer of InflaRx, said: "We are pleased that the phase IIb study in Hidradenitis Suppurativa is advancing
according to plan. The goal with this trial is to determine the optimal dose regimen, as well as assess both the long-term efficacy
and safety of IFX-1 in patients with this disease. We look forward to advancing to the next stages of development in this important
Hidradenitis Suppurativa (HS)
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 2 to 3), 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.
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 and has, to date, successfully completed three clinical phase II studies. More than 150 people
have been treated with IFX-1 in these completed clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is
currently being developed for various inflammatory indications, including Hidradenitis Suppurativa and ANCA-associated vasculitis.
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 and New York, NY.
Development and Strategy
Jordan.silverstein[at]inflarx.de
Laurie Doyle, Andreas Jungfer
inflarx[at]mc-services.eu
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