Galapagos provides further insights into the treatment of
ulcerative colitis at the upcoming United European Gastroenterology
(UEG) Week 2022 congress
- Five presentations demonstrate Galapagos' commitment to
inflammation and the ulcerative colitis (UC) community
- New analyses will be presented from the SELECTION data set on
prediction of response and remission, histology data and trajectory
model
- Presentation on safety data of filgotinib in enriched risk
population in rheumatoid arthritis
Mechelen, Belgium;
6 October 2022, 22.01
CET, Galapagos NV (Euronext &
NASDAQ: GLPG) will present data
at the United European Gastroenterology
(UEG)
Week
2022,
taking place from
8-11 October
2022. Several Galapagos
driven presentations will be showcased,
including new post
hoc analyses of the SELECTION
study, which investigated the
safety and efficacy of
Jyseleca®
(filgotinib),
an oral,
once-daily, JAK1
preferential inhibitor, in
patients with moderately to severely active
UC.
Dr Walid Abi-Saab, Chief Medical officer of
Galapagos said, “We continue to analyze data from the different
studies of filgotinib in patients with UC to inform and empower
healthcare professionals to make the most appropriate choices for
patients. We are committed to making a real difference to patients
by finding ways to better treat this debilitating condition and are
excited to share these data and insights at the UEG Week.”
In addition to clinical data presentations,
Galapagos is also hosting a hybrid symposium:
‘JAK to the future – a patient centric
choice in UC’ on Monday 10 October 2022,
which will feature experts’ perspectives on taking a
patient-centric, comprehensive approach to disease control as the
best approach to address current unmet needs in UC management and
on how the JAK class can help HCPs navigate the current and future
treatment landscape.
Scientific Abstracts:
Title |
Authors |
Presentation date/time |
Galapagos-driven abstracts |
|
Trajectory modelling to identify different types of individual
response to therapy: a post hoc analysis from the
SELECTION study |
Stefan Schreiber, Laurent Peyrin-Biroulet, Toshifumi Hibi, Louis
Dron, Sichen Liu, Claus A. Andersen, Alessandra Oortwijn,
Haridarshan Patel, Brian Feagan |
Poster Number: MP443Date: Tuesday, October 11,
14:00–15:00Presentation time: 14:12 – 14:18 (6 min incl. 3 min
discussion)Session: Response prediction in IBD
- Moderated Poster |
Predictors of response to filgotinib in ulcerative
colitis: post hoc analysis from the SELECTION study |
Brian Feagan, Laurent Peyrin-Biroulet, Edouard Louis, Virginia
Taliadouros, Franck-Olivier Le Brun, Alessandra Oortwijn,
Haridarshan Patel, Angela de Haas, Tadakazu Hisamatsu |
Poster Number: MP447Date: Tuesday, October 11,
14:00–15:00Presentation time: 14:36 – 14:42 (6 min incl. 3 min
discussion)Session: Response prediction in IBD
- Moderated Poster |
Use of faecal calprotectin as a prognostic marker of response to
treatment with filgotinib: post hoc analysis from the
SELECTION study |
Edouard Louis, Brian Feagan, Tadakazu Hisamatsu, Virginia
Taliadouros, Rob Jongen, Alessandra Oortwijn, Carole Van der
Donckt, Laurent Peyrin-Biroulet |
Poster Number: P0353Date: Sunday, October 9,
08:00–19:30Session: E-Poster Session -
Science LoungeOn-site poster round: Monday, October 10,
12:30-13:30 Terminal 20: Lower GI |
Assessment of histological remission in patients treated with
filgotinib by different scores and concordance with endoscopic and
health-related quality of life outcomes: post
hoc analysis from the SELECTION study |
Fernando Magro, Laurent Peyrin-Biroulet, Gerhard Rogler, Alessandra
Oortwijn, Haridarshan Patel, Angela de Haas, Eva Santermans, Haoyao
Ruan, Louis Dron, Brian Feagan |
Poster Number: P0488Date: Sunday, October 9,
08:00–19:30Session: E-Poster Session -
Science LoungeOn-site poster round: Tuesday, October 11,
12:30-13:30 Terminal 21: Lower GI |
Exploratory analysis of filgotinib safety data in a selected
population of patients with rheumatoid arthritis: data from FINCH
1–4 and DARWIN 1–3 studies in perspective to integrated ulcerative
colitis safety data |
Stefan Schreiber, Maya H. Buch, Xavier Mariette, Gerd R. Burmester,
Christina Charles-Schoeman, Vijay Rajendran, Nadia Verbruggen,
Agustin Cerani, Paul Van Hoek, Katrien Van Beneden, Alessandra
Oortwijn, Yoshiya Tanaka, Ennio Giulio Favalli, Hendrik
Schulze-Koops, René Westhovens, Severine Vermeire |
Poster Number: P0418Date: Sunday, October 9,
08:00–19:30Session: E-Poster Session -
Science Lounge |
About
ulcerative
colitis Ulcerative colitis
(UC) is a debilitating inflammatory bowel disease (IBD) that occurs
as a result of an abnormal immune system response. Across Europe an
estimated 2.5 - 3 million people1 are affected by IBD, which
includes UC and Crohn’s disease (CD). UC is a chronic inflammatory
condition characterized by periods of flare ups followed by
remission. In addition to the physical impact from flare ups, there
is also a psychological impact associated with UC. It causes
significant impairments on quality of life and a poor prognosis is
often seen in patients with symptoms of moderate to severe UC at
diagnosis.
About the SELECTION
studyThe SELECTION Phase 3 study is a
multi-center, randomized, double-blind, placebo-controlled study to
assess the safety and efficacy of the preferential JAK1 inhibitor
filgotinib in adult patients with moderately to severely active UC.
The SELECTION study (NCT02914535) comprises two induction trials
and a maintenance trial. The Induction Study A enrolled
biologic-naïve patients, and the Induction Study B enrolled
biologic-experienced patients.
The primary objectives of SELECTION were to
evaluate the efficacy of filgotinib compared with placebo in
establishing clinical remission as determined by the Mayo
endoscopic subscore of 0 or 1, rectal bleeding sub-score of 0, and
≥ 1-point decrease in stool frequency from baseline to achieve a
sub-score of 0 or 1 at Week 10 in the induction studies and Week 58
in the maintenance study. Eligible patients who were enrolled in
the SELECTION study were enrolled in the ongoing SELECTION
long-term extension trial to evaluate the long-term safety of
filgotinib in patients with UC. A majority of patients included in
the SELECTION study (n=1348) had a Mayo Clinic Score (MCS) of 9 or
higher at baseline, and 43% of biologic experienced patients
(n=297/689) had insufficient response to a TNF antagonist and
vedoluzimab as well. (Feagan et al., Lancet 2021; 397: 2372–84)
About
filgotinibFilgotinib is marketed as Jyseleca
(200mg and 100mg tablets) in the European Union (incl. Norway),
Great Britain, and Japan for the treatment of adults with
moderately to severely active rheumatoid arthritis (RA) who have
responded inadequately or are intolerant to one or more disease
modifying anti-rheumatic drugs (DMARDs). Filgotinib is also
marketed as Jyseleca (200mg tablets) in the European Union (incl.
Norway), Great Britain, and Japan for the treatment of adult
patients with moderately to severely active ulcerative colitis (UC)
who have had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a biologic agent. A
global Phase 3 program with filgotinib is ongoing in Crohn’s
Disease. More information about clinical trials can be accessed
at https://www.clinicaltrials.gov.
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
moderately to severely 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 Phase 4
programs in inflammation, oncology, fibrosis, and other
indications. Our first medicine for rheumatoid arthritis and
ulcerative colitis is available in the European Union, Norway,
Great Britain, and Japan. For additional information, please visit
www.glpg.com or follow us
on LinkedIn or Twitter.
ContactInvestors: Sofie
Van Gijsel Head of Investor Relations +1 781 296
1143
Sandra Cauwenberghs Director Investor Relations +32
495 58 46 63 ir@glpg.com
Media: Marieke Vermeersch Head of
Corporate Communication
+32 479 490 603 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 are not always, made through the
use of words or phrases such as “may,” “upcoming,” “future,”
“potential,” “will,” and “plan,” as well as similar expressions.
Forward-looking statements contained in this release include, but
are not limited to, statements regarding Galapagos’ plans and
strategy with respect to Jyseleca and the DARWIN, SELECTION, and
FINCH studies. Any forward-looking statements in this release are
based on Galapagos 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 Galapagos’ actual results, performance or
achievements to be materially different from any historic or future
results, performance or achievements expressed or implied by such
forward-looking statements. These risks, uncertainties and other
factors include, without limitation, the risk that ongoing and
future clinical studies with filgotinib may not be
completed in the currently envisaged timelines or at all, the
inherent risks associated with clinical trial and product
development activities, including the filgotinib clinical program
and the DARWIN, SELECTION, and FINCH studies, the
inherent risks and uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements (including that data from the
ongoing and planned clinical research programs, including but not
limited to the data from the ongoing DARWIN, SELECTION, and FINCH
studies, may not support registration or further development
of filgotinib due to safety, efficacy or other
reasons), the risks related to continued regulatory review of
filgotinib following approval by relevant regulatory authorities,
including EMA’s safety review of JAK inhibitors used to treat
certain inflammatory disorders, the risks that regulatory
authorities may require additional post-approval trials of
filgotinib or any other product candidates that are approved in the
future, Galapagos' reliance on collaborations with third
parties (including our collaboration partner for filgotinib,
Gilead) and that Galapagos’ estimations regarding
its filgotinib development program and regarding the
commercial potential of filgotinib may be incorrect, the
risk that Galapagos will not be able to continue to execute on its
currently contemplated business plan and/or will need to revise its
business plan, and risks related to the ongoing 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 Galapagos’ 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. Galapagos expressly disclaims any
obligation to update any such forward-looking statements in this
release unless required by law or regulation.
1 Burisch J. et al. Journal of Crohn’s and
Colitis (2013); 7:322-337.
- Galapagos provides further insights into the treatment of
ulcerative colitis at the upcoming United European Gastroenterology
(UEG) Week 2022 congress
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