InflaRx Provides Development Update for Vilobelimab in Pyoderma Gangrenosum and Severe COVID-19
June 29 2022 - 7:30AM
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, provided a development update today for its
first-in-class monoclonal anti-C5a antibody, vilobelimab, in
pyoderma gangrenosum (PG) and severe COVID-19.
Vilobelimab has been granted orphan drug
designation for the treatment of PG by both the Food and Drug
Administration (FDA) in the US and the European Medicines Agency
(EMA) in Europe. In addition, the Company had a productive
end-of-phase II meeting with the FDA related to its plans for a
Phase III development program in PG. The FDA indicated its support
for a randomized, controlled Phase III development program during
the meeting and offered to review the study protocol, recognizing
PG as a serious and rare condition. Based on the Agency’s feedback
and recommendations, InflaRx is now finalizing the design for a
Phase III trial and continues to be in dialogue with the agency
related to this.
Following the encouraging Phase III results from
the randomized, placebo-controlled, multi-national PANAMO study in
mechanically ventilated severe COVID-19 patients announced earlier
this year, InflaRx requested a meeting with the FDA to obtain
guidance with respect to a potential emergency use authorization
submission. This has been scheduled as a Type B meeting for early
Q3. In addition, the Company is in ongoing dialogue with the EMA
related to next steps in the development of vilobelimab in
mechanically ventilated severe COVID-19 patients towards a
potential filing for approval for this indication.
“We are pleased to see our development in
pyoderma gangrenosum moving forward with the granting of the orphan
drug designation by FDA and EMA and with the productive discussions
we have had with the FDA regarding our pivotal development program
for this disease which is painful and debilitating for patients and
can be life threatening,” said Prof. Niels C. Riedemann, CEO and
Founder of InflaRx. “We also are looking forward to discussing our
vilobelimab results in severe COVID-19 with the regulatory agencies
in the US and Europe in greater detail to understand next steps
towards a potential emergency use authorization or approval. Our
team believes that the robust survival results from our COVID-19
PANAMO study provide important scientific insights in the potential
benefits of C5a inhibition even beyond COVID-19.”
The Company further reports that Jordan Zwick,
Chief Strategy Officer, has left InflaRx to pursue an opportunity
in business development. Mr. Zwick has agreed to continue to serve
as an advisor to the Company. Prof. Riedemann commented: “Jordan
has been a great member of our team and contributed to important
developments in the Company with his experience and always positive
energy. While he will be missed by our team, we wish him all the
best in his future career, and we look forward to staying
connected.”
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 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, including the
development of vilobelimab to treat pyoderma gangrenosum (PG) and
severe COVID-19, and related communications with the FDA; 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; decisions regarding the strategic direction of our company;
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 an emerging growth company and/or
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.
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