InflaRx Provides Update on Development Plans for Vilobelimab in Hidradenitis Suppurativa
February 28 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 an
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). The feedback indicates that the
FDA recommends using the Hidradenitis Suppurativa Clinical Response
Score (“HiSCR”) as the primary endpoint in the Phase III trial. The
FDA advice was provided nearly three months after the Company’s
protocol submission and contrasts with the FDA advice provided to
the Company in a Type A meeting held in Q3 2021. In the minutes of
that meeting, FDA provided advice on how to implement, name and
validate the meaningfulness of the modified HiSCR, a new primary
endpoint suggested by the Company, that would measure the reduction
of all three types of inflammatory lesions in HS – inflammatory
nodules, abscesses and draining tunnels. A reduction in draining
tunnels is not captured by the HiSCR. Within the Type A written
response, FDA did not recommend the traditional HiSCR as the
primary endpoint measure. Following the advice received in the Type
A meeting, earlier this year, InflaRx announced the initiation of a
Phase III trial, designed to study patients with moderate to severe
HS disease suffering from actively draining tunnels.
Given the unexpected details of the feedback
from the FDA, InflaRx will pause activities related to the Phase
III trial. The Company will seek to clarify the advice received and
determine next steps, which will be communicated accordingly. The
FDA has not issued a clinical hold.
As previously announced, InflaRx completed a
Type A meeting with the FDA in Q3 2021 to align on the Phase III HS
study design. In this meeting, FDA and InflaRx discussed together a
new primary efficacy endpoint for a pivotal study program that
focuses on patients with active draining tunnels and includes
measuring the reduction of all three types of inflammatory lesions.
InflaRx incorporated the FDA’s input and submitted the Phase III
protocol to the Agency in late November 2021. The FDA had no
comments during the 30-day nor the 60-day review period. In Q1
2022, InflaRx determined it was appropriate to begin study
activities, as the Company did not expect any critical protocol
review issues to be pending with FDA.
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
pyoderma gangraenosum. 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 OfficerJason Stewart –
Strategy & Investor RelationsEmail: 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 STATEMENTSThis 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; 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.
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