Mechelen,
Belgium; 4 June
2021;
07.01
CET; –
Galapagos NV (Euronext & Nasdaq: GLPG) today announced
that primary and secondary endpoint
results from the phase 3 SELECTION
induction and maintenance study
(NCT02914522) were published in
The Lancet
(doi.org/10.1016/S0140-6736(21)00666-8).
The study, sponsored by
Gilead Sciences,
Inc., was designed to assess the
efficacy and safety of the once-daily, oral preferential JAK1
inhibitor, filgotinib, under
investigation in patients with moderately
to severely active ulcerative colitis
(UC).
In addition to the primary and secondary
endpoints, which have been reported at the United European
Gastroenterology congress in October 2020 and can be
found on the Galapagos website, www.glpg.com/press-releases, the
publication also reports data from a post-hoc analysis by induction
cohort of filgotinib 200mg versus placebo during the maintenance
study on multiple efficacy endpoints. These include sustained
clinical remission, 6-month corticosteroid free remission, Mayo
Clinic Score (MCS), endoscopic and histologic remission, MCS
response and endoscopic improvement. Across all these
endpoints, numerically greater differences in favor of
filgotinib 200mg compared to placebo were shown. This is
reported independent of previous biologic treatment status
(biologic-naïve and biologic-experienced) with an overall larger
numerical effect among biologic-naïve patients1.
A further post-hoc analysis in the publication
reports mucosal healing, a composite endpoint defined as endoscopic
improvement (Mayo endoscopy score 0-1) and histological remission
in the same patient. The proportion of patients achieving mucosal
healing after 10 weeks of induction treatment with filgotinib 200mg
was numerically greater compared with placebo (23.3% vs 10.9% in
biologic-naïve and 9.9% vs 4.2% in biologic-experienced) and at
week 58 in the overall study population (32.7% vs 10.2%)2.
Dr. Walid Abi-Saab, Chief Medical Officer at
Galapagos said, “Achieving early and sustained remission from
symptoms, combined with mucosal healing are key goals of therapy in
ulcerative colitis. These analyses suggest a positive treatment
effect on a range of measures, including mucosal healing, across a
broad patient population, which includes those who have failed
conventional therapy as well as those who have failed previous
biologics.”
The incidence of adverse events (AEs), serious
adverse events (SAEs) and discontinuations due to AEs were similar
in the filgotinib and placebo groups in both the induction and
maintenance periods of the study. In the induction studies, SAEs
occurred in 4.7%, 5.0% and 4.3% of patients who received placebo,
filgotinib 100mg and 200mg respectively. In the maintenance study,
SAEs were experienced by 4.5% of patients in the filgotinib 100mg
group and 7.7% in the respective placebo group and by 4.5% of
patients in the filgotinib 200mg group and no patients in the
respective placebo group. Exposure adjusted incidence rates of SAEs
were similar across treatment groups in the induction and
maintenance studies. Two deaths were observed in the filgotinib
200mg treatment group in the maintenance trial; both adverse events
leading to deaths were considered by the study investigators as
unrelated to study drug.
UC is a long-term condition characterized by
inflammation of the mucosal lining of the colon and rectum. As an
increasingly prevalent disease, UC has a significant impact on the
quality of life of more than 2 million people across Europe.
Despite current treatments, many patients experience fecal urgency,
incontinence, recurring bloody diarrhea, and the need to empty
their bowels frequently, often accompanied by abdominal pain, poor
sleep, and fatigue.
The use of filgotinib for UC is investigational
and not approved anywhere globally. Its efficacy and safety have
not been established.
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.
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 score of 9 or
higher at baseline, and 43% of biologic experienced patients had
insufficient response to a TNF antagonist and vedolizumab as
well.
Data on the primary endpoint showed that a
greater proportion of biologic-naïve and biologic-experienced
patients receiving filgotinib 200mg achieved clinical remission at
Week 10 than those on placebo (26.1% versus 15.3% p=0.0157 and
11.5% versus 4.2% p=0.013 respectively). This clinical remission
was maintained up to 58 weeks for those receiving filgotinib 200mg
versus those receiving placebo (37.2% versus 11.2% p<0.001). The
difference for filgotinib 100mg was not statistically significant
in the induction study, however in the maintenance study at Week 58
a statistically significant difference was seen versus placebo
(23.8% versus 13.5%, p=0.0420).
Overall, the incidence of adverse events (AEs),
serious AEs and discontinuations due to AEs were similar in
the filgotinib and placebo groups in both the induction
and maintenance periods of the study, as reported above.
For SELECTION study information visit:
https://clinicaltrials.gov/ct2/show/NCT02914522For access to
SELECTION in The Lancet publication visit;
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00666-8/fulltext
1 Feagan. B., et al: Filgotinib as induction and maintenance
therapy for ulcerative colitis: the SELECTION trial. The Lancet
https://doi.org/10.1016/S0140-6736(21)00666-8. Appendix page 29,
Table S42 Feagan. B., et al: Filgotinib as induction and
maintenance therapy for ulcerative colitis: the SELECTION trial.
The Lancet https://doi.org/10.1016/S0140-6736(21)00666-8. Appendix
page 15, Figure S5
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 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
and Japan a global Phase 3 program is ongoing in Crohn’s Disease.
More information about clinical trials can be accessed at
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 late-stage 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.
Contacts
Investors:Elizabeth GoodwinVP
Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+32 485 19 14
15ir@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 statementsThis
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, competitive developments, and regulatory
approval requirements, including the risk that data from the
ongoing and planned clinical research programs with filgotinib may
not support registration or further development in UC or other
indications 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, the uncertainty regarding
estimates of the commercial potential of filgotinib, the timing of
and the risks related to completing and implementing the amendment
of our arrangement with Gilead for the commercialization and
development of Jyseleca (filgotinib), 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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