Full Press Release Details
InflaRx Reports Full Year 2023 Results
and Announces INF904 Development Plans
Jena, Germany, March 21, 2024
- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics by targeting the complement system,
today announced its financial and operating results for the year ended December 31, 2023, and provided a comprehensive strategic update
on its future development and operational plans.
Prof. Niels C. Riedemann, Chief Executive
Officer and Founder of InflaRx, commented: "InflaRx has recently made tremendous progress in its pipeline, with vilobelimab
now in Phase III for PG and INF904 emerging as a potentially best-in-class oral C5aR inhibitor with broad commercial potential. It's
with great excitement that we unveil our new pipeline focus directed at sizable markets and unmet needs in immuno-dermatology where our
unique approach to C5a and C5aR inhibition may provide significant benefits. We believe that InflaRx can drive incremental pipeline value
in this field given our expertise and network. Furthermore, with the potential of INF904 to be a pipeline-in-a-product', we are
considering partnering options to unlock additional value in other areas of interest."
Prof. Dr. Marcus Maurer, Chairman of
Dermatology and Allergology, Institute of Allergology, Charit University, Berlin, Germany, commented: "I am very
excited about the development of INF904 and its initial focus on the immuno-dermatology field, including CSU where our group has
worked out and communicated to InflaRx a potential role of C5aR in the disease pathology. As a potent oral inhibitor of
C5aR, I believe there is a strong rationale to pursue development of INF904 in CSU, a condition with high unmet patient need and
where new mechanisms of action are needed. I look forward to future collaboration with InflaRx on this promising agent."
Christopher Sayed, MD, Prof. of Dermatology,
University of North Carolina, Medical School; and Secretary of the HS Foundation, commented: "There has been accumulating evidence
from clinical studies, some of which I have been involved in, that C5a and C5aR inhibition may provide substantial benefit to HS patients.
Especially the observed effect on reduction of draining tunnels, one of the most life-impacting and difficult to treat lesions has been
remarkable as this remains a high unmet medical need. I am excited to see INF904 being developed as an oral C5aR inhibitor in HS, which
could represent a promising new treatment option for these patients who need more and differentiated therapies."
Pipeline update event today; R&D
day to follow later this year
InflaRx will host a virtual pipeline
update call today, beginning at 8:00 AM ET / 1:00 PM CET to discuss its focus on immuno-dermatology. The company will provide
details on the development rationales for its chosen indications for its oral C5aR inhibitor INF904 and provide an update on the
development of vilobelimab in PG.
To participate in the conference call,
participants may pre-register at https://us06web.zoom.us/webinar/register/WN_fbW4HAzuRyq_A710WVzslg#/registration and will receive a
dedicated link and dial-in details to easily and quickly access the call. An accompanying updated corporate deck can be found on InflaRx's website at https://www.inflarx.de/Home/Investors/Events---Presentations.html.
InflaRx is also planning a virtual
research and development event to follow later this year to provide more details on its development plans and to offer insights from
key opinion leaders into the development and commercial rationales of InflaRx's pipeline.
Immuno-dermatology pipeline focus:
INF904 for CSU and HS
InflaRx has chosen two initial
immuno-dermatology indications that it intends to pursue with INF904 via the initiation of a Phase IIa "basket study".
These indications initially include CSU and HS, two chronic inflammatory skin conditions in which C5a has been suggested to play a
significant role and where a high unmet need exists. In addition, with INF904 being an oral drug with a mechanism of action
currently not addressed by other drugs in development for these indications, the company sees a unique opportunity to improve
standard of care for patients with these conditions. InflaRx estimates significant market potential for INF904 in these two
indications, both estimated as multi-billion-dollar markets.
InflaRx is currently conducting additional
pre-clinical studies, including chronic toxicology studies, to enable longer-term dosing of INF904. Consistent with previous
communications, InflaRx anticipates initiating a Phase IIa study with INF904 before the end of 2024. This open-label Phase IIa study
is expected to explore at least three different doses of INF904 for a duration of 4 weeks and to assess pharmacokinetic (PK) and
pharmacodynamic (PD) parameters in patients, as well as provide safety data and certain early efficacy readouts. Data from this
Phase IIa study is expected to be released in 2025. InflaRx expects to initiate a larger and longer-term Phase IIb study in 2025 as
CSU is a debilitating and unpredictable skin disease
characterized by intensely itchy hives / wheals and angioedema. The burden of this chronic disease is high and impacts sleep, mental health,
quality of life and productivity due to absences from school and work. CSU is estimated to affect around 40 million people worldwide.
CSU patients have been reported to show elevated
C5a levels, a major activator of mast cells and basophils, which are thought to be significant contributors to CSU pathogenesis. In addition,
studies suggest that complement activation (including C5a) in CSU can lead to histamine release.
Current treatments are limited, and a significant
unmet need exists in a sizable proportion of patients. As an orally available agent with a favorable PK / PD profile that could drive
a broad dose range for systemic exposure, INF904 could find a differentiated position in the CSU market.
HS is a chronic, recurrent, debilitating neutrophil-driven
inflammatory disease that can persist for years and tremendously impacts quality of life; it is characterized by abscesses, nodules and
draining tunnels which can flare and cause scarring.
INF904 inhibits the known C5a-induced effects
on neutrophil activation and tissue accumulation of immune cells, including generation of tissue damaging mechanisms (enzyme release and
oxidative radical formation) as well as induction of NETosis - mechanisms thought to be involved in HS progression and draining
tunnel formation. Clinical evidence with existing C5a/C5aR products also supports that blocking this pathway reduces lesion counts.
Patients' responses to treatment with approved
anti-TNF-alpha or anti-IL17 drugs are known to wane over time in a significant number of cases, and treatments with new mechanisms are
needed for these patients. As an orally available agent with a favorable PK / PD profile that could drive a broad dose range for systemic
exposure, INF904 could find a differentiated and commercially advantageous place in HS treatment.
INF904 as a "pipeline-in-a-product"
Given the potential of INF904 to have a broad
commercial footprint, InflaRx believes it could address meaningful markets in immuno-dermatology and in immuno-inflammation,
including in neurology, nephrology and hematology. While InflaRx intends to focus its resources on its immediate goals with CSU and
HS, it also assesses pursuit of these additional areas via potential future collaborations with partners.
Immuno-dermatology pipeline focus: Vilobelimab
InflaRx's strategy and planning for vilobelimab
in PG remain unchanged and its development is currently on track. InflaRx is conducting a multi-national, randomized, double-blind, placebo-controlled
pivotal Phase III study with vilobelimab for the treatment of ulcerative PG, a rare, chronic inflammatory form of neutrophilic dermatosis
characterized by accumulation of neutrophils in the affected skin areas. The trial study has two arms: (1) vilobelimab plus a low dose
of corticosteroids and (2) placebo plus the same low dose of corticosteroids. The primary endpoint of the study is complete closure of
the target ulcer at any time up to 26 weeks after initiation of treatment.
The study has an adaptive design with an interim
analysis blinded for the sponsor and investigators planned upon enrollment of approximately 30 patients (15 per arm). Depending on the
results of the interim analysis, the trial sample size will be adapted, or the trial will be terminated due to futility. The enrollment
period is projected to be at least two years, depending on the total trial size after sample size adaptation.
Vilobelimab has been granted orphan drug designation
for the treatment of PG by both the U.S. Food and Drug Administration (FDA) in the United States and the European Medicines Agency in
Europe, as well as fast track designation by the FDA.
Select 2023 and recent operational highlights
INF904 - Positive topline results from
Phase I trial support best-in-class potential
In January 2024, InflaRx reported results from
the multiple ascending dose (MAD) part of a randomized, double-blind, placebo-controlled Phase I trial in healthy volunteers to assess
the safety, tolerability and PK / PD properties of its orally administered, low molecular weight C5aR inhibitor, INF904.
The safety analysis of INF904 in the Phase I study
demonstrated that it was well tolerated in participants over the entire dose range and resulted in no safety signals of concern. There
were no serious or severe adverse events observed at any dosing level. Both the single ascending dose (SAD) and the MAD part of the study