DGAP-News: InflaRx announces positive phase IIa top-line results from the SCIENS trial investigating IFX-1, a first-in-class anti-complement C5a antibody

DGAP-News: InflaRx GmbH / Key word(s): Study results
InflaRx announces positive phase IIa top-line results from the SCIENS trial
investigating IFX-1, a first-in-class anti-complement C5a antibody

29.01.2016 / 07:05
The issuer is solely responsible for the content of this announcement.

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InflaRx announces positive phase IIa top-line results from the SCIENS trial
investigating IFX-1, a first-in-class anti-complement C5a antibody

Jena, Germany, January 28th 2016 - InflaRx, a biopharmaceutical company
developing new therapeutics in the terminal complement space, announced
today positive results from its SCIENS phase IIa clinical trial of IFX-1, a
first-in-class monoclonal anti-C5a antibody. The trial reached all primary
endpoints and demonstrated safety, tolerability and biological proof of
concept of IFX-1 in patients suffering from early septic organ dysfunction.

IFX-1 highly statistically significantly reduced and effectively blocked
C5a in a dose-dependent manner. In addition, the data showed positive
trends in various other clinically relevant efficacy endpoints, such as
organ dysfunction score (SOFA score), need for ventilator support and
length of stay on the ICU. IFX-1 is the first monoclonal anti-C5a antibody
introduced into clinical development, which has now successfully completed
a clinical phase II study in patients.

Prof. Niels Riedemann, co-founder and CEO of InflaRx commented, "After 15
years of focused research and development around C5a, one of the most
promising targets in inflammation, we are excited that we can now
demonstrate the power of our technology in patients. We developed IFX-1 to
become a game-changer in the intensive care field and these new results
bring us a big step closer to this goal."

The SCIENS trial enrolled 72 patients suffering from early septic organ
dysfunction in a placebo controlled double blinded dose escalation design
and was conducted within the SepNet study trial group in 15 German
Intensive Care Units. The study investigated the
pharmacokinetics/pharmacodynamics (PK/PD), safety and tolerability of IFX-1
as well as various exploratory secondary clinical endpoints. Furthermore,
it represents a first-in-class clinical trial in the infectious acute care
space, as it enrolled focus-selected patients with early organ dysfunction
within only 3.5 hours after screening, to evaluate the benefits of an early
intervention.

"We designed this study to gain in-depth knowledge about IFX-1 consumption
and complement activation in this patient population. We will use the
upcoming weeks to carefully analyze all data in order to tailor the planned
phase IIb trial in this vital area of unmet medical need," Dr. Othmar
Zenker, Head of Clinical R&D noted.

"InflaRx has taken a highly innovative clinical trial approach in
investigating this very promising antibody to tackle one of the most
life-threatening events within the entire acute care field: inflammation
induced organ failure. Based on these encouraging results, we are
optimistic that the further development of IFX-1 could be of significant
benefit to patients and doctors in this devastating condition, where thus
far no therapy is available," concluded Prof. Michael Bauer, study PI
appointed Chairman of Anesthesiology and Intensive Care Medicine and
Chairman of the Center for Sepsis Control and Care at the Jena University
Hospital.

About septic organ dysfunction and complement C5a: In serious infections,
the body's immune system activates inflammatory response mechanisms which
have been described as cause of self-induced tissue and organ damage, such
as oxygen radical formation, enzyme and cytokine release by activated blood
cells and various others. This damage quickly results in organ dysfunction
and ultimately organ failure which is the lead cause of death of patients
in most intensive care units worldwide. Similar mechanisms have been
described in other infectious settings such as Malaria, Dengue Fever and
others, but also in non-infectious inflammation, such as large operations,
burn or trauma. Various international scientific groups and the InflaRx'
founders have identified C5a as a key "amplifying factor" of most such
acute inflammatory responses. In experimental models, early blockade of C5a
resulted in a preservation of organ function and improved survival by
down-regulation of the immune cell induced tissue damage and various other
inflammatory responses.

About IFX-1: IFX-1 is a first-in-class monoclonal anti-human complement C5a
antibody which demonstrates a complete biological blocking activity and
selectivity towards its target, C5a, leaving the important defense
mechanism of C5b-9 formation intact. IFX-1 is thought to control the
inflammatory response driven tissue and organ damage by specifically
blocking C5a as a key "amplifier" of this response. IFX-1 is currently in
clinical phase II development for various different acute and
life-threatening inflammatory indications.

About InflaRx: InflaRx is a biopharmaceutical company focusing on the
development of new therapeutics controlling the inflammatory response based
on its proprietary technology.. InflaRx has developed a pipeline of
first-in-class antibodies directed against the terminal complement
component C5a. While IFX-1 focuses on the acute care space, its product
candidates, IFX-2 and IFX-3, are being developed in chronic inflammatory
disease indications. InflaRx was founded in 2007 and is headquartered in
Jena, Germany, with long standing research collaborations in the US and
China. The team consists of renowned experts in complement research and
clinical acute care. InflaRx is privately owned and financed by bm-t
Beteiligungsmanagement Thüringen Gmbh, KfW banking group and various
international family offices.

Contacts:

InflaRx GmbH
Niels C. Riedemann - CEO
Email: info[at]inflarx.de
Tel: +49-3641-508180
www.inflarx.de

MC Services AG
Katja Arnold / Dr. Cora Kaiser
Email: katja.arnold[at]mc-services.eu / cora.kaiser[at]mc-services.eu
Tel: +49-89-210 2280

The Trout Group
Jennifer Porcelli / Thomas Hoffmann
Email: JPorcelli[at]troutgroup.com / thoffmann[at]troutgroup.com
Tel: +1 646 378 2900


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29.01.2016 Dissemination of a Corporate News, transmitted by DGAP - a
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The issuer is solely responsible for the content of this announcement.

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