InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, announced today positive topline results from
its U.S. Phase II IXPLORE study with vilobelimab in patients with
anti-neutrophil cytoplasmic auto-antibody (ANCA)-associated
vasculitis, or AAV.
“ANCA-associated vasculitis is an organ and
life-threatening disease. Although current treatments for AAV are
quite helpful in many patients, there are still unmet needs for
fast-acting, effective, and safe treatments and alternatives to the
regular use of high-dose glucocorticoids,” said Dr. Peter A.
Merkel, Chief of Rheumatology and Professor of Medicine at the
University of Pennsylvania. “Research suggests C5a has an important
role in the pathogenesis of AAV, and blockade of C5a offers the
opportunity to address several of these unmet needs. The results of
the IXPLORE trial show C5a blockade by vilobelimab is safe and well
tolerated when added to standard of care therapy for AAV. These
results support the continued study of vilobelimab for the
treatment of AAV.”
“We are pleased to report that vilobelimab was
safe and well tolerated in combination with standard of care for
patients with ANCA-associated vasculitis in the U.S. IXPLORE Phase
II trial,” said Dr. Korinna Pilz, Global Head of Clinical Research
and Development. “We are looking forward to our EU IXCHANGE Phase
II trial results later this year where we are further evaluating
the potential efficacy of vilobelimab alone compared to a standard
dose of glucocorticoids. The results from these two trials will
provide us good insight to plan our next development steps in this
important indication.”
U.S. Phase II IXPLORE Study Design and
Topline Results
The randomized, double-blind, placebo-controlled
Phase II study enrolled 19 patients in the U.S. (NCT 03712345). The
study compared two different dose regimens of vilobelimab to
placebo. All patients received current standard of care
immunosuppressive therapy and high dose glucocorticoids (SOC). The
primary endpoint of the study was to evaluate the safety of
vilobelimab, as this was the first time the drug was being
administered to patients with AAV in the U.S. Important efficacy
parameters included response and remission rates based on the
Birmingham Vasculitis Score (BVAS), a validated and
well-established score in AAV. Patients were randomized into three
groups:
- SOC plus
placebo;
- SOC plus 400 mg
vilobelimab q2w; and
- SOC plus 800 mg
vilobelimab q2w
Patients were treated for 16 weeks (including a
fractionated loading dose at days 4 and 8) followed by an
observation period of 8 weeks.
The IXPLORE safety study met its primary
objective: Across all groups, a similar number of patients
experienced one or more treatment-emergent adverse events
(TEAEs).
- TEAEs:
- 5 of 6 patients
(SOC plus placebo)
- 7 of 7 patients
(SOC plus vilobelimab 400 mg)
- 6 of 6 patients
(SOC plus vilobelimab 800 mg)
In addition, a similar number of patients
experienced TEAEs rated as drug-related by investigators:
- Any drug-related
TEAE:
- 3 of 6 patients
(SOC plus placebo)
- 3 of 7 patients
(SOC plus vilobelimab 400 mg)
- 2 of 6 patients
(SOC plus vilobelimab 800 mg)
Overall, no safety signal of concern could be
detected in the study, as observed TEAEs are reflective of the
disease and SOC treatment.
At baseline, patients in the higher dose
vilobelimab group (800 mg) showed a higher Birmingham Vasculitis
Activity Score (BVAS) of 17.5 mean / 16.5 median, when compared to
the baseline BVAS scores of the SOC group (13.8 mean / 13.5 median)
and the 400 mg vilobelimab group (13.1 mean / 12.0 median).
The IXPLORE study was not powered to show
statistical significance on efficacy endpoints; however, clinical
response and remission for each treatment group was measured at
week 16 as secondary efficacy endpoints using the BVAS. The
proportion of patients achieving a clinical response was defined as
a 50% reduction in BVAS at week 16 (and no worsening in any body
system) compared to baseline, and clinical remission was defined as
BVAS=0.
Although the sample size of the trial was small
and it is difficult to interpret results not powered to show
statistical significance, patients across all three treatment
groups demonstrated a strong response at week 16, and more patients
treated with SOC plus vilobelimab had clinical remissions at
various timepoints throughout the study compared to SOC plus
placebo:
Clinical Response at Week 16:
Dose |
SOC plus placeboN=6 |
SOC plus 400 mg vilobelimabN=7 |
SOC plus 800 mg vilobelimabN=5* |
Responders |
6 (100%) |
6 (85.7%) |
5 (100%) |
*one patient at week 16 did not attend the
visit
Clinical Remission at various timepoints:
Dose |
SOC plus placeboN=6 |
SOC plus 400 mg vilobelimab N=7 |
SOC plus 800 mg vilobelimab N=6 |
Combined vilobelimab groups N=13 |
Remissions at Week 4 |
1 (16.7%) |
3 (42.9%) |
1 (20%)* |
4 (33.3%)* |
Remissions at Week 8 |
1 (16.7%) |
4 (57.1%) |
2 (33.3%) |
6 (46.2 %) |
Remissions at Week 12 |
3 (50%) |
5 (71.4 %) |
3 (50%) |
8 (61.5%) |
Remissions at Week 16 |
4 (66.7%) |
6 (85.7%) |
3 (60%)* |
9 (75%)* |
Remissions at Week 20 |
3 (50%) |
5 (71.4%) |
3 (75%)** |
8 (72.7%)** |
Remissions at Week 24 |
3 (50%) |
5 (71.4%) |
4 (80%)* |
9 (75%)* |
*one patient did not attend the visit at
timepoint
**two patients did not attend the visit at
timepoint
InflaRx plans to present more detailed trial
results at a future medical meeting.
As previously reported, both Part 1 and Part 2
of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled.
Data from the randomized, double-blind, placebo-controlled trial
with 57 patients are expected by the end of 2021.
About ANCA-associated vasculitis
(AAV):
AAV is a rare and life-threatening autoimmune
disease in which activation of the complement system, and
specifically the generation of larger amounts of C5a, is believed
to play a key role in the neutrophil-driven vessel inflammation
that defines the disease. AAV affects approximately 40,000 and
75,000 patients in the United States and Europe, respectively.
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 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,
cutaneous squamous cell carcinoma 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:
IR@inflarx.de Tel: +1 917-338-6523
MC Services AG
Katja Arnold, Laurie Doyle, Andreas
JungferEmail: inflarx@mc-services.eu Europe: +49 89-210
2280US: +1-339-832-0752
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