InflaRx Receives Corrected Advice Letter from FDA Related to Phase III Program for Vilobelimab in Hidradenitis Suppurativa
March 17 2022 - 7:30AM
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, today reported that the Company has received a
corrected advice letter from the U.S. Food and Drug Administration
(FDA) related to its Phase III program with vilobelimab for the
treatment of hidradenitis suppurativa (HS). In this corrected
letter, FDA no longer recommends that the Company use the
Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the
primary endpoint for the chosen patient population but gives
recommendations related to implementation of the modified HiSCR
(m-HiSCR).1 The written advice letter received in February 2022 had
stated that the Agency recommended using the HiSCR as the primary
endpoint in the Phase III trial, which was inconsistent with the
minutes from a Type A advice meeting held between InflaRx and the
FDA in the third quarter of 2021.
“We appreciate the prompt feedback from the FDA
clarifying the advice received in February,” stated Dr. Korinna
Pilz, Chief Clinical Development Officer.
In light of this corrected advice from FDA,
InflaRx believes that further development in HS is feasible. Given
the additional financing needs for a full Phase III HS program and
the recent promising data in another immuno-dermatological disease,
pyoderma gangrenosum, InflaRx is currently evaluating its strategic
options on how to most efficiently develop vilobelimab in this
disease space.
The Company plans to update the markets on its
pipeline development strategy in the second quarter of 2022.
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 in pre-clinical
studies to control the inflammatory response driven tissue and
organ damage by specifically blocking C5a as a key “amplifier” of
this response. Vilobelimab is believed to be the first monoclonal
anti-C5a antibody introduced into clinical development. Over 300
people have been treated with vilobelimab in completed clinical
trials, and the antibody has been shown to be well tolerated.
Vilobelimab is currently being developed for various indications,
including hidradenitis suppurativa, and has recently reported
positive Phase II results in ANCA-associated vasculitis and Phase
IIa results in pyoderma gangrenosum. Vilobelimab is in Phase III
development for the treatment of critically ill COVID-19 patients
and in Phase II development for patients suffering from cutaneous
squamous cell carcinoma (cSCC).
About InflaRx N.V.InflaRx
(Nasdaq: IFRX) is a clinical-stage biopharmaceutical company
focused on applying its proprietary technology to discover and
develop first-in-class or best-in-class, potent and specific
inhibitors of C5a and C5aR. Complement C5a and C5aR are powerful
inflammatory mediators 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:
IR@inflarx.deTel: +1 917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas JungferEmail: inflarx@mc-services.euEurope:
+49 89-210 2280US: +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
pre-clinical development and clinical trials, in particular our
Phase III trial in HS and related communications with the FDA, in
particular addressing the FDA’s advice in various communications to
us regarding the primary endpoint for the Phase III trial; 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.
________________________1: m-HiSCR is defined as achieving both
i) total body inflammatory lesion count (ANdT) reduction from
Baseline of at least 50% and ii) a draining tunnel (dT) count
reduction from Baseline of at least 50% at the end of Week 16.
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