Galapagos initiates Phase 3 program with filgotinib in patients
with active axial spondyloarthritis
- OLINGUITO Phase 3 program in adults with axial
spondyloarthritis (AxSpA) to include two parallel studies to
investigate the efficacy and safety of filgotinib in patients with
active radiographic AxSpA (r-AxSpA) and non-radiographic AxSpA
(nr-AxSpA)
- Results from Phase 2 TORTUGA study
showed that filgotinib 200mg was efficacious and well-tolerated in
patients with r-AxSpA
- Filgotinib, an oral, once-daily
JAK1 preferential inhibitor, is currently approved in Europe and
Japan for the treatment of rheumatoid arthritis (RA) and ulcerative
colitis (UC)
Mechelen,
Belgium; 26
April
2023,
22:01 CET; Galapagos NV (Euronext &
NASDAQ: GLPG) today announced that
the first patient
was randomized
in OLINGUITO,
the pivotal
Phase 3 program
of filgotinib in
AxSpA.
Topline results are expected in
H2 2025.
In the Phase 2 TORTUGA study, filgotinib 200mg
achieved significantly greater improvements in Ankylosing
Spondylitis Disease Activity Score (ASDAS)1 at Week 12, the primary
endpoint, and had an encouraging safety profile in patients with
active r-AxSpA who had not responded to conventional
treatment.2
“Axial spondyloarthritis is a chronic, painful,
highly invalidating inflammatory condition that can profoundly
impact patients’ quality of life,” said Prof. Xenofon Baraliakos,
Professor of Internal Medicine and Rheumatology at Ruhr-University
Bochum, Germany and Coordinating Investigator of the study. “There
is a high unmet need for effective oral treatment options for this
condition. I am pleased that the first trial sites have been
initiated and look forward to continuing to work with Galapagos and
with the other study sites to rapidly enroll patients in this
pivotal trial.”
“Patients with AxSpA face a significant disease
burden and given the limited available therapies, there remains a
high unmet medical need for effective oral treatment options,” said
Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, Immunology, at
Galapagos. “Filgotinib has demonstrated a consistent efficacy and
safety profile across a range of patient populations, and
inflammatory conditions and has the potential to address the needs
of patients living with AxSpA. We look forward to advancing the
OLINGUITO program and to working collaboratively with our clinical
partners.”
The OLINGUITO global Phase 3 program
(NCT05785611) consists of two randomized, placebo-controlled,
double-blind, multi-center, parallel-group studies. The objectives
of the studies are to investigate the efficacy and safety of orally
administered filgotinib for 16 weeks in 476 patients with active
r-AxSpA (Study A) and nr-AxSpA (Study B) who have had an inadequate
response to conventional or biological treatment. Each study will
enroll approximately 238 patients who are randomized 1:1 to receive
filgotinib 200mg or placebo once-daily. The primary endpoint for
Study A and Study B is the proportion of patients who achieve an
ASAS403 response at Week 16 in compliance with the European
Medicines Agency’s (EMA) guidelines. The double-blind studies will
be followed by an open-label treatment period in which all patients
will receive filgotinib 200mg once-daily up to Week 52. Patients
from Study A and Study B who achieve sustained low disease activity
in the open-label treatment period will be re-randomized 1:1 at
Week 52 to receive double-blind filgotinib 100mg or 200mg up to
Week 104.
About axial
spondyloarthritisAxial spondyloarthritis (AxSpA),
also known as ankylosing spondylitis is a chronic inflammatory
disease that involves primarily the sacroiliac joints (SIJs) and
the spine, and is characterized by pain, stiffness and fatigue
often leading to functional impairment. There are two distinct
clinical presentations of AxSpA, radiographic and non-radiographic.
In patients with radiographic AxSpA (r-AxSpA), the disease is
confirmed by the presence of damage in the SIJ on x-Ray. In
non-radiographic AxSpA (nr-AxSpA), this sign is absent, and
presence of disease is confirmed by MRI or genetic features (i.e.
presence of HLA B27). First symptoms indicative of AxSpA tend to
develop in young adults, aged 20 to 30 years. Typical early
symptoms of the disease include inflammatory back pain, which is
characterized by nocturnal pain and prolonged morning stiffness of
the (lower) back with impaired physical function. Many patients
present with articular (arthritis, dactylitis) and extra-articular
(for example inflammatory bowel disease, uveitis, psoriasis)
symptoms associated with AxSpA. Studies report the prevalence of
AxSpA ranges from 9 to 30 per 10,000 in the general population,
depending on geographic area, study population or data source, case
definition, and ascertainment methods.4
About
filgotinibFilgotinib is marketed as Jyseleca® in
Europe and Japan for the treatment of adults with moderate to
severe active RA who have responded inadequately or are intolerant
to one or more disease modifying anti-rheumatic drugs. Filgotinib
is also marketed as Jyseleca® in Europe and Japan for the treatment
of adult patients with moderate to severe active UC who have had an
inadequate response with, lost response to, or were intolerant to
either conventional therapy or a biologic agent. Jyseleca® 100mg
and 200mg are registered in the above-mentioned
territories. The European Summary of Product Characteristics
for filgotinib, which includes contraindications and special
warnings and precautions, is available at www.ema.europa.eu. The
Great Britain Summary of Product Characteristics for filgotinib can
be found at www.medicines.org.uk/emc and the Northern Ireland
Summary of Product Characteristics for filgotinib can be found at
www.emcmedicines.com/en-GB/northernireland, respectively. The
interview form from the Japanese Ministry of Health, Labour and
Welfare is available at www.info.pmda.go.jp.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies. Except for
filgotinib’s approval as Jyseleca® for the treatment of moderate to
severe active RA and UC by the relevant regulatory authorities in
the European Union, Great Britain, and Japan, our drug candidates
are investigational; their efficacy and safety have not been fully
evaluated by any regulatory authority.
About GalapagosGalapagos is a
fully integrated biotechnology company focused on discovering,
developing, and commercializing innovative medicines. We are
committed to improving patients’ lives worldwide by targeting
diseases with high unmet needs. Our R&D capabilities cover
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to
commercialized programs in immunology, oncology, and other
indications. Our first medicine for rheumatoid arthritis and
ulcerative colitis is available in Europe and Japan. For additional
information, please visit www.glpg.com or follow us
on LinkedIn or Twitter.
Contacts
Media
relations |
Investor
relations |
Marieke
Vermeersch |
Sofie Van
Gijsel |
+32 479
490 603 |
+1 781 296
1143 |
|
|
Elisa
Chenailler |
Sandra
Cauwenberghs |
+41 79 853 33
54 |
+32 495 58 46
63 |
|
ir@glpg.com |
Hélène de
Kruijs |
|
+31 6
22463921 |
|
media@glpg.com |
|
Forward Looking Statements
This press release includes forward-looking
statements, all of which involve certain risks and uncertainties.
These statements are often, but not always, made through the use of
words or phrases such as “will,” “can,” “commit,” “potential,”
“remains,” “continue,” “rapid,” “unmet,” “advance,” “encouraging,”
“working,” “consists,” “achieve,” and “improve,” as well as similar
expressions. Forward-looking statements contained in this release
include, but are not limited to, statements related to our plans
and strategy with respect to filgotinib, including our planned
Phase 3 clinical trial in AxSpA, r-AxSpA and nr-AxSpA with
filgotinib, and the OLINGUITO or TORTUGA study, statements in
relation to the envisaged timelines for the OLINGUITO study, and
statements regarding the timing with respect to the OLINGUITO
study. Any forward-looking statements in this release are based on
our management’s current expectations and beliefs and are not
guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
which might cause our actual results, performance or achievements
to be materially different from any historic or future results,
performance or achievements expressed or implied by such
statements. These risks, uncertainties and other factors include,
without limitation, the risk that the clinical study
with filgotinib for AxSpA, r-AxSpA and nr-AxSpA, OLINGUITO, and any
future clinical studies with filgotinib may not be completed in the
currently envisaged timelines or at all, the inherent risks and
uncertainties associated with competitive developments, clinical
trial and product development activities, including with respect to
the OLINGUITO study, risks related to regulatory approval
requirements (including that data from the ongoing and planned
clinical research programs may not support the registration of
filgotinib for indications in AxSpA, r-AxSpA and/or nr-AxSpA due to
safety, efficacy or other reasons), risks related to our reliance
on collaborations with third parties, the risk that our estimations
regarding our filgotinib development program and regarding the
commercial potential of filgotinib may be incorrect, the risk that
we will not be able to continue to execute on our currently
contemplated business plan and/or will need to revise our business
plan, and risks related to the COVID-19 pandemic, as well as those
risks and uncertainties identified in our most recent Annual Report
on Form 20-F filed with the U.S. Securities and Exchange Commission
(SEC), as supplemented and/or modified by any other filings and
reports that we have made or will make with the SEC in the future.
Given these risks and uncertainties, the reader is advised not to
place any undue reliance on such forward-looking statements. In
addition, even if our results, performance or achievements are
consistent with such forward-looking statements, they may not be
predictive of results, performance or achievements in future
periods. These forward-looking statements speak only as of the date
of publication of this release. We expressly disclaim any
obligation to update any such statements in this release unless
required by law or regulation.
1 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is
an index to assess disease activity in Ankylosing Spondylitis
(AS).2 Van Der Heijde D. Efficacy and safety of filgotinib, a
selective Janus kinase 1 inhibitor, in patients with active
ankylosing spondylitis (TORTUGA): results from a randomised,
placebo-controlled, phase 2 trial Lancet 2018;392:2378-87.3
Percentage of Participants Achieving SpondyloArthritis
International Society 40% improvement.4 Wang R, Ward MM.
Epidemiology of axial spondyloarthritis: an update. Curr Opin
Rheumatol. 2018 Mar;30(2):137-143.
- Galapagos initiates Phase 3 program with filgotinib in patients
with active axial spondyloarthritis
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