Galapagos announces completion of patient enrollment for DIVERSITY
Phase 3 study with filgotinib in Crohn’s Disease
-
1,374 patients
enrolled into the phase 3 study
across 369 global
sites
- Topline data anticipated in
H1
2023
- Galapagos will
assume responsibility
for the
DIVERSITY
study
Mechelen, Belgium; 4
October 2021,
07.01 CET; Galapagos NV (Euronext &
NASDAQ: GLPG) today announced randomization
of the last patient into
the
multi-center,
global DIVERSITY Phase 3
study. The study is
designed to evaluate the efficacy and safety of filgotinib,
a JAK1 preferential inhibitor, in
the induction and maintenance of remission in patients
with Crohn’s Disease
(CD).
The DIVERSITY study enrolled
1,374 participants with moderately to severely active CD,
including biologic-naïve and biologic-experienced patients. The
study evaluates the safety and efficacy of 100mg and 200mg
filgotinib versus placebo on clinical remission and endoscopic
response, in a 10-week induction phase, followed by a 47-week
maintenance phase. Topline results of the DIVERSITY study are
anticipated in H1 2023.
Dr. Walid Abi-Saab, Chief Medical Officer,
Galapagos NV said: “This is an important milestone in the DIVERSITY
program, as it brings us closer to delivering robust evidence to
assess the use of our JAK1 preferential inhibitor as a potentially
new class of medicine in the treatment of patients with Crohn's
Disease. I would like to thank the patients and the clinical trial
centers for participating in this important program, especially
during the recent COVID-19 pandemic, which has been a particularly
challenging time for the health services and society as a
whole.”
The DIVERSITY clinical program design
was informed by results from the Phase 2 FITZROY study,
with filgotinib, which provided positive results for the
use of this JAK1 inhibitor in patients with active CD. Full
results were reported in The Lancet.1
The use of filgotinib for CD is investigational
and is not approved anywhere globally.
Galapagos will
assume operational and financial
responsibility for DIVERSITYIn
agreement with Gilead, Galapagos will assume sponsorship of and
operational and financial responsibility for the ongoing DIVERSITY
clinical study, evaluating filgotinib in CD, and its long-term
extension study. The parties intend to complete the transfer no
later than June 30, 2022. Under the terms of the agreement and upon
completion of the transfer, Gilead will make a one-time payment of
$15 million to Galapagos in consideration for Galapagos assuming
responsibility for the DIVERSITY clinical study. From April 1,
2022, Galapagos will also be solely responsible for all development
costs for the DIVERSITY clinical study. In addition, if the
European Medicines Agency grants regulatory approval of filgotinib
for the treatment of CD based on data from the DIVERSITY trial,
then royalties payable by Galapagos to Gilead will be reduced by
30% across all filgotinib indications and will become 5.6 to 10.5%
of net sales in Europe. These royalties are payable as of 2024.
Gilead remains responsible for commercial activities outside of
Europe.
About Crohn’s
DiseaseCrohn’s disease is a type of inflammatory bowel
disease in which the well-controlled balance of the intestinal
immune system is disturbed. CD causes ulcerations that may affect
any part of the digestive system from mouth to anus. The cause of
the disease is unknown, with onset usually between the ages of 15
and 35. Patients suffer from abdominal pain, diarrhea (often
blood), vomiting, fever and weight loss. Estimates suggest there
could be up to 1.6 million people living with CD across Europe and
up to 78,000 new cases every year.2
About the
DIVERSITY Phase 3
StudyDIVERSITY consists of a combined,
double-blind, placebo-controlled Phase 3 study, enrolling
1,374 patients from 369 centers worldwide. The study compares
the efficacy of filgotinib 100mg or 200mg once-daily oral treatment
versus placebo in the induction and maintenance of clinical
remission measured by Crohn’s Disease Activity Index (CDAI) score
and endoscopic response measured as simple endoscopic score for
Crohn’s Disease (SES-CD) at week 10 and week 58, in
biologically-naive and biologically-experienced patients with
moderately to severely active CD. There are EU-specific co-primary
objectives that evaluate clinical remission measured by Patient
Reported Outcome (PR02) and endoscopic response (SES-CD) at Week-10
and Week-58. In addition to clinical endpoints the study will also
evaluate the effects on Health-Related Quality of Life (HRQoL)
scores and Health Care Resource Utilization (HCRU) at Week-10 and
Week-58. Safety will be evaluated by assessment of clinical
laboratory tests, physical examination, vital signs measurements at
various timepoints during the study, and by the documentation of
Adverse Events.
For DIVERSITY study information visit: ClinicalTrials.gov
Identifier NCT02048618
About the filgotinib
collaborationGilead and Galapagos NV are partners in a
global collaboration to develop and commercialize filgotinib, which
is approved and marketed as Jyseleca® 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). Galapagos will be responsible for
the commercialization of filgotinib in Europe (transition from
Gilead to Galapagos 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. Applications to extend the approved indication of filgotinib
to include ulcerative colitis have been filed in the European
Union, Great Britain, 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.
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 individual Great
Britain and Northern Ireland Summary of Product Characteristics can
be found
at www.medicines.org.uk/emc and www.emcmedicines.com/en-GB/northernireland respectively.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies.
About Galapagos Galapagos NV
discovers, develops, and commercializes small molecule medicines
with novel modes of action. Our pipeline comprises discovery
through Phase 3 programs in inflammation, fibrosis, and other
indications. Our ambition is to become a leading global
biopharmaceutical company focused on the discovery, development,
and commercialization of innovative medicines. More information at
www.glpg.com.
Contact
Investors:Elizabeth GoodwinVP
Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+1 781 296
1143
Sandra CauwenberghsDirector Investor Relations+32 495 58 46
63ir@glpg.com
Media:Anna GibbinsSenior Director Therapeutic
Areas Communications+44 7717 801900
Evelyn FoxDirector Executive Communications +31 65 3591
999 communications@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
DIVERSITY study and filgotinib clinical program, the timeline of
topline results from clinical trials, competitive developments, and
regulatory approval requirements, including the risk that the
results of the DIVERSITY study may not support continued approval
of filgotinib or may not support registration or further
development in CD or other indications due to safety or efficacy
concerns 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, 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, the risk that the
parties would not be able to complete the contemplated transfer of
the DIVERSITY STUDY in a timely manner or at all, the risk that
parties may not be able to successfully implement transfer of
rights and activities in a timely or efficient manner or at all,
Galapagos’ reliance on collaborations with third parties, including
the collaboration with Gilead for filgotinib, the risk that
Galapagos’ estimations regarding its filgotinib development program
may be incorrect and the uncertainty regarding estimates of the
commercial potential of filgotinib, the risks and costs involved in
selling and marketing filgotinib, the timing of and risks related
to the implementation of the transition of the European
commercialization responsibility of filgotinib from Gilead to us,
including the risk that the transition will not be completed on the
currently contemplated timeline or at all, and the risk that the
transition will not have the currently expected results for our
business and results of operations; and the uncertainties relating
to the impact of the COVID-19 pandemic on our strategy, business
plans and focus, 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.
1 The Lancet Vol. 389 No. 10066 p266–275 Published: December 14,
20162 Journal of Crohn's and Colitis, Volume 7, Issue 4, May 2013,
Pages 322
337, https://doi.org/10.1016/j.crohns.2013.01.0103 https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
(last accessed 01.09.21)
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