InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum
06 July 2022 - 9:30PM
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, today announced that the US Food and Drug
Administration (FDA) granted a Fast Track designation to the
development of its first-in-class anti-C5a monoclonal antibody
vilobelimab for the treatment of ulcerative pyoderma gangrenosum
(PG). The Company had submitted a request for Fast Track
designation to the FDA on the positive outcome data in PG from its
Phase IIa open-label dose-escalation study.
As previously announced, in the multi-center,
proof-of-concept Phase IIa study a total of 19 patients were
enrolled. Over a treatment period of 26 weeks, patients were
treated biweekly with vilobelimab 800mg, 1600mg or 2400mg, after an
initial run-in phase with three doses of 800mg on days 1, 4 and 8,
followed by a two-month observation period. Efficacy was assessed
with the physician global assessment score (PGA), and 6 out of 7
patients (85.7%) in the high dose cohort demonstrated complete
target ulcer closure and treatment response correlated with
suppression of C5a levels in patients’ plasma over time.
The Company had previously announced that
vilobelimab was granted orphan drug designation for the treatment
of PG by both the FDA in the US and the European Medicines Agency
(EMA) in Europe and that the Company had held a productive
End-of-Phase II meeting with the Division of Dermatology with the
FDA related to its Phase III development plans in PG.
“We are pleased that our development in pyoderma
gangrenosum has been designated Fast Track by the FDA shortly after
receiving the Orphan Drug designation, recognizing PG as serious
condition with high unmet medical need and vilobelimab as promising
potential future treatment option,” said Prof. Niels C. Riedemann,
CEO and Founder of InflaRx. “The Fast Track designation will
further facilitate our interactions with the FDA related to our
development in PG and will also allow for faster review and
approval upon successful completion of a Phase III development
program,” he added.
About Fast Track1
Fast track is a process designed by the FDA to
facilitate the development and expedite the review of drugs to
treat serious conditions and fill an unmet medical need. According
to the FDA, the purpose is to get important new drugs to the
patient earlier. A drug that receives Fast Track designation is
eligible for some or all of the following:
- more frequent
meetings with FDA to discuss the drug's development plan and ensure
collection of appropriate data needed to support drug
approval;
- more frequent
written communication from FDA about such things as the design of
the proposed clinical trials and use of biomarkers;
- eligibility for
Accelerated Approval and Priority Review, if relevant criteria are
met; and
- Rolling Review,
which means that a drug company can submit completed sections of
its Biologic License Application (BLA) or New Drug Application
(NDA) for review by FDA, rather than waiting until every section of
the NDA is completed before the entire application can be
reviewed.
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. Vilobelimab has been
shown to be well tolerated within clinical trials in different
disease settings. Vilobelimab is currently being developed for
various indications, including pyoderma gangrenosum and severe
COVID-19. The Company has recently reported positive Phase IIa
results in PG and encouraging Phase III results in mechanically
ventilated COVID-19 patients. Vilobelimab is also in Phase II
development for patients suffering from cutaneous squamous cell
carcinoma.
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. Email:
IR@inflarx.de
MC Services AG Katja Arnold,
Laurie Doyle, Andreas Jungfer Email:
inflarx@mc-services.eu Europe: +49 89-210 2280 US:
+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, including the
development of vilobelimab to treat pyoderma gangrenosum (PG) and
severe COVID-19; the impact of the COVID-19 pandemic on us; 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; our status as a foreign private
issuer; 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 See U.S. Food and Drug Administration,
“Fast Track,” available online.
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