InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, today provided an update on the ongoing
development of vilobelimab (IFX-1), a first-in-class anti-C5a
antibody.
Prof. Niels C. Riedemann, Chief Executive
Officer and Founder of InflaRx, said: “Despite the challenges of
COVID-19, we made strong development progress with vilobelimab in
2020. We also are happy to be able to do our part in fighting the
ongoing pandemic as we evaluate vilobelimab in patients with severe
COVID-19, who as we all know are in desperate need of safe and
effective treatments. Looking to the year ahead, we expect to have
several important data readouts. We are also excited that we will
soon start our first trial in oncology, an important new indication
for vilobelimab.”
OncologyThe Company today
announced plans to start an open label, multicenter Phase II study
evaluating vilobelimab alone and in combination with pembrolizumab
in patients with PD-1 or PD-L1 inhibitor resistant/refractory
locally advanced or metastatic cutaneous squamous cell carcinoma
(cSCC).
cSCC is the second most common nonmelanoma skin
cancer/keratinocyte carcinoma and represents 20% to 50% of all skin
cancers. Although the majority of cSCCs are successfully excised
surgically, a subset has features associated with a higher
likelihood of recurrence, metastasis, and death.
The non-comparative two-stage Phase II trial is
expected to start in the first half of 2021 and will be a
multi-national study, including sites in Europe, the US and
elsewhere. The study investigates two independent arms: vilobelimab
alone and vilobelimab in combination with pembrolizumab. The main
objectives of the trial are to assess the antitumor activity and
safety of vilobelimab monotherapy and to determine the maximum
tolerated or recommended dose, safety and antitumor activity in the
combination arm.
Hidradenitis Suppurativa
(HS)The Company has been assessing different strategies to
progress the clinical development of vilobelimab for HS in the
United States. InflaRx plans to submit a Special Protocol
Assessment (SPA) to the Food & Drug Administration (FDA) for
the Phase III trial in Hidradenitis Suppurativa in the first
quarter of 2021. Details on the Phase III design will be provided
once an agreement has been reached with the FDA.
SPA is a process in which a company may ask to
meet with the FDA to reach an agreement on the design and size of a
trial to determine if it adequately addresses scientific and
regulatory requirements for a study that could support marketing
approval. An SPA agreement indicates concurrence by FDA with the
adequacy and acceptability of specific critical elements of overall
protocol design (e.g., entry criteria, dose selection, endpoints,
and planned analyses) for a study intended to support a future
marketing application.
InflaRx believes the SPA provides the best way
forward to reach an agreement on the trial design for its pivotal
Phase III program with the FDA.
In Europe, as previously reported in 2020,
InflaRx had positive scientific advice from the European Medicines
Agency (EMA) about the European pathway for regulatory approval,
including supporting the use of a new primary endpoint, the
International Hidradenitis Suppurativa Severity Score (IHS4). The
Company is working diligently to address the additional feedback
received to achieve alignment with the US strategy for a global
Phase III development program in HS.
Severe COVID-19The Phase III
part of the global Phase II/III trial evaluating vilobelimab in
mechanically ventilated patients with COVID-19 was initiated in
mid-September, and recruitment is currently ongoing in Europe, with
other regions in the process of being added. The study is enrolling
as planned with a total goal of 360 patients. A blinded interim
analysis is planned after 180 patients, with a potential early stop
of the trial for efficacy or futility. Topline data
from the trial are expected to be available in 2021.
InflaRx is a founding member of the Biotech
Emergency Alliance for Therapies against COVID-19 (BEAT-COV), an
association of four German medium-sized biotechnology companies
with promising COVID-19 therapeutic approaches in late stages of
clinical development. The initiative calls on policymakers in
Germany to take clear decisions to promote the development of
therapeutics for COVID-19 patients. BEAT-COV calls for significant
government support to finance and to speed up late-stage clinical
development, production, approval, and market launch of targeted
treatment options.
ANCA-associated Vasculitis
(AAV)InflaRx recently reported the completion of
enrollment in the European Phase II IXCHANGE study of vilobelimab
in AAV. Topline data from the randomized, double-blind,
placebo-controlled trial with 57 patients are expected by the end
of 2021.
Vilobelimab is also being studied in the US
Phase II IXPLORE study in patients with AAV. The main objective of
this randomized, double-blind, placebo-controlled study is to
evaluate the safety of vilobelimab, as this is the first time the
drug is being administered to patients with AAV in the US. Topline
results are expected by mid-2021.
Pyoderma Gangraenosum The Phase
IIa open label trial continues to enroll patients in the higher
dose groups. Promising initial data from the first five patients in
the study were announced in 2020. Results from the higher dose
groups are expected in 2021.
About vilobelimab
(IFX-1):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 to control the inflammatory response driven
tissue and organ damage by specifically blocking C5a as a key
“amplifier” of this response in pre-clinical studies. Vilobelimab
is believed to be the first monoclonal anti-C5a antibody introduced
into clinical development. Approximately 300 people have been
treated with vilobelimab in clinical trials, and the antibody has
been shown to be well tolerated. Vilobelimab is currently being
developed for various indications, including Hidradenitis
Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum,
cancer and severe COVID-19.
About InflaRx N.V.:InflaRx
(Nasdaq: IFRX) is a clinical-stage biopharmaceutical company
focused on applying its proprietary anti-C5a technology to discover
and develop first-in-class, potent and specific inhibitors of C5a.
Complement C5a is a powerful inflammatory mediator 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 OfficerEmail:
jordan.zwick@inflarx.deTel: +1 917-338-6523
MC Services AG
Katja 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
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