New post-hoc analyses of data from SELECTION
Phase 3 program presented at European Crohn’s and Colitis
Organisation (ECCO) virtual congress
Mechelen,
Belgium; 10 July 2021,
11.10
CET; Galapagos NV (Euronext & NASDAQ: GLPG) today
announced new post-hoc
analyses from the Phase
3 SELECTION program, supporting
the activity and tolerability of
filgotinib, a
once-daily, oral JAK1
preferential inhibitor, under
investigation for the treatment of patients with
moderately to severely active ulcerative colitis (UC). These data
were presented at the European Crohn’s and Colitis
Organisation (ECCO) 16th annual
congress.
A post-hoc analysis of the induction study data
from SELECTION showed significant improvements in patient-reported
outcomes (PROs) of stool frequency (SF) and of rectal bleeding
(RB), that were observed as early as the first week of therapy in
patients on 200mg of filgotinib daily versus placebo in patients
with moderately to severely active UC. These findings were observed
in both biologic-naïve and biologic-experienced patients. More
patients receiving filgotinib 200mg versus placebo achieved a
composite score of RB=0 and SF≤1 as early as day 9 in Induction
study A (biologic-naïve; filgotinib 200mg 18.8%, placebo 9.5%,
p<0.05) and as early as day 7 in Induction study B
(biologic-experienced; filgotinib 200mg 10.7%; placebo 4.2%,
p<0.05).1
A further post-hoc analysis of the SELECTION
maintenance study reported the proportion of patients who were
steroid-free at different timepoints, before achieving remission at
Week 58. These data indicated that filgotinib 200mg reduced and
eliminated corticosteroid (CS) use versus placebo at Week 58 in
patients with moderately to severely active UC. Compared with
placebo, a significantly higher proportion of patients who
demonstrated CS-free remission at Week 58 with filgotinib 200mg had
been CS-free in the previous six months (27% filgotinib 200mg vs 6%
placebo, 95% CI 21 (8, 34), with a difference seen from as early as
the previous eight months (22% filgotinib 200mg vs 6% placebo, 95%
CI 15 (3, 28)).2
Additional safety analysis from SELECTION,
combining induction, maintenance and the long-term extension study
data, with a cumulative treatment exposure of 1,207 patient years
for filgotinib 200mg versus 318 patient years for placebo, showed
results consistent with the original induction and maintenance
trials, where filgotinib was well tolerated in patients with
moderately to severely active UC.3
Walid Abi-Saab, Chief Medical Officer at
Galapagos stated, “Listening to the needs of patients living with
moderately and severely active UC, and the healthcare professionals
treating them, helps us understand the importance of finding
treatments that address both clinical symptoms and patient reported
outcomes. These new data from SELECTION and the long-term extension
study suggest that patients with moderately to severely active UC
have experienced rapid response, sustained steroid-free remission
and long-term tolerability when taking filgotinib 200mg versus
those on a placebo”.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic type of inflammatory bowel
disease (IBD) that occurs as a result of an abnormal immune system
response. Across Europe an estimated 2 million people4 are affected
by IBD, which includes UC and Crohn’s Disease (CD). It is a chronic
inflammatory condition of the gastrointestinal (GI) tract. The
disease course of UC is often a state of flare ups and ensuing
periods of remission. In addition to the physical impact from flare
ups, there is also a significant psychological impact associated
with UC, which is further compounded by the perceived stigma of the
condition.
About the SELECTION Phase 3
TrialThe SELECTION Phase 3 trial is a multi-center,
randomized, double-blind, placebo-controlled trial to assess the
safety and efficacy of the preferential JAK1 inhibitor filgotinib
in adult patients with moderately to severely active UC. The
SELECTION trial 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.
Across both induction studies, 1348 patients
with moderately to severely active UC were randomized to receive
either filgotinib 200mg, filgotinib 100mg or placebo in a 2:2:1
ratio. Moderately to severely active UC was defined as a centrally
read endoscopy score ≥ 2, a rectal bleeding score ≥ 1, a stool
frequency score ≥ 1 and Physician Global Assessment (PGA) of ≥ 2
based on the Mayo Clinic Score (MCS). 644 patients with clinical
remission or response at Week 10 of induction were subsequently
re-randomized to the induction dose of filgotinib or placebo in a
2:1 ratio and treated through Week 58.
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 subscore of 0, and ≥
1-point decrease in stool frequency from baseline to achieve a
subscore 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 trial were enrolled in the ongoing SELECTION
long-term extension trial to evaluate the long-term safety of
filgotinib in patients with moderately to severely active UC. A
majority of patients included in the trials had a MCS of 9 or
higher at baseline, and 43% of biologic experienced patients had
insufficient response to a TNF antagonist and vedolizumab as
well.
For SELECTION study information visit:
https://clinicaltrials.gov/ct2/show/NCT02914522
About filgotinib Filgotinib is
approved and marketed as Jyseleca (200mg and 100mg tablets) in the
European Union, Great Britain, and Japan for the treatment of
adults with moderate to severe active rheumatoid arthritis (RA) who
have responded inadequately or are intolerant to one or more
disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be
used as monotherapy or in combination with methotrexate (MTX). The
European Summary of Product Characteristics for filgotinib, which
includes contraindications and special warnings and precautions, is
available at www.ema.europa.eu. The interview form from the
Japanese Ministry of Health, Labour and Welfare is available at
www.info.pmda.go.jp. The Great Britain and Northern Ireland Summary
of Product Characteristics is available at
www.medicines.org.uk/emc. Applications have been submitted to the
European Medicines Agency (EMA), the UK’s Medicines and Healthcare
products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals and
Medical Devices Agency (PMDA) for the treatment of adults with
moderately to severely active ulcerative colitis who have had an
inadequate response with, lost response to, or were intolerant to
either conventional therapy or a biologic agent and are currently
under review. Filgotinib is not approved in any other
countries.
About the filgotinib
collaborationGilead and Galapagos NV are collaborative
partners in the global development and commercialization of
filgotinib. Galapagos will be responsible for the commercialization
of filgotinib in Europe (transition anticipated to be completed by
end of 2021), while Gilead will remain responsible for filgotinib
outside of Europe, including in Japan, where filgotinib is
co-marketed with Eisai. Filgotinib in UC has been filed in Europe,
the UK and Japan, and a global Phase 3 program is ongoing in
Crohn’s Disease. More information about clinical trials can be
accessed at https://www.clinicaltrials.gov
About Galapagos Galapagos NV
discovers, develops, and commercializes small molecule medicines
with novel modes of action, several of which show promising patient
results and are currently in development in multiple diseases. Our
pipeline comprises discovery through Phase 3 programs in
inflammation, fibrosis and other indications. Our ambition is to
become a leading global biotech company focused on the discovery,
development and commercialization of innovative medicines. More
information at www.glpg.com.
- Danese. S, et al. Rapidity of symptom improvements during
filgotinib induction therapy in patients with Ulcerative Colitis:
post hoc analysis of the phase 2b/3 SELECTION study. OP37, ECCO
Congress 2021
- Loftus, E, et al. Corticosteroid-free remission of Ulcerative
Colitis with filgotinib maintenance therapy: post hoc analysis of
the phase 2b/3 SELECTION study DOP82, ECCO Congress 2021
- Schreiber. S, et al. Safety analysis of filgotinib for
Ulcerative Colitis: results from the phase 2b/3 SELECTION study and
phase 3 SELECTIONLTE long-term extension study. OP04, ECCO Congress
2021
- Burisch J. et al. The burden of inflammatory bowel disease in
Europe. Journal of Crohn’s and Colitis (2013) 7, 322-337
Contacts
Investors:Elizabeth GoodwinVP
Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+1 781 296
1143ir@glpg.com
Media:Carmen VroonenGlobal Head of
Communications & Public Affairs+32 473 824 874
Anna GibbinsSenior Director Therapeutic Areas Communications+44
7717 801900communications@glpg.com
Forward Looking
Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, that are subject to risks,
uncertainties and other factors that could cause actual results to
differ materially from those referred to in the forward-looking
statements and, therefore, the reader should not place undue
reliance on them. These risks, uncertainties and other factors
include, without limitation, the inherent risks associated with
clinical trial and product development activities, including the
SELECTION study, competitive developments, and regulatory approval
requirements, including the risk that the results of the
SELECTION study may not support continued approval
of Jyseleca for the treatment of adults with moderately
to severely active ulcerative colitis who have had an inadequate
response with, lost response to, or were intolerant to either
conventional therapy or a biologic agent due to safety,
efficacy or other reasons , the timing or likelihood of
regulatory authorities approval of marketing authorization for
filgotinib for UC or any other indications, such regulatory
authorities requiring additional studies, Galapagos’ reliance on
collaborations with third parties, including the collaboration with
Gilead for filgotinib, Galapagos’ estimations regarding its
filgotinib development program and regarding the commercial
potential of filgotinib, risks related to the implementation of the
transition of the European commercialization responsibility to us,
as well as those risks and uncertainties identified in our Annual
Report on Form 20-F for the year ended 31 December 2020 and our
subsequent filings with the SEC. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The forward-looking statements
contained herein are based on management’s current expectations and
beliefs and speak only as of the date hereof, and Galapagos makes
no commitment to update or publicly release any revisions to
forward-looking statements in order to reflect new information or
subsequent events, circumstances or changes in
expectations.
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