The Lancet publishes FITZROY study results with filgotinib in Crohn's disease
December 15 2016 - 4:36AM
Mechelen, Belgium; 12 December 2016 - Galapagos
NV (Euronext & NASDAQ: GLPG) reports publication of the Phase 2
study with filgotinib in Crohn's disease in The Lancet.
"Filgotinib, a selective JAK1 inhibitor, induces
clinical remission in patients with moderate-to-severe Crohn's
disease: results from the phase II double-blind, randomized,
placebo-controlled FITZROY study," by Dr Severine Vermeire et al.
describes the study design and full results and can be found online
at www.glpg.com/filgotinib.
"Filgotinib could represent the first new oral
treatment for CD in many years, and Phase 3 trials with the
compound are underway," said Dr Vermeire. "FITZROY was the first
double-blind, placebo-controlled study to use centrally read
endoscopies to ensure the selective recruitment of patients with
active disease including mucosal ulceration."
The Lancet also publishes an editorial that
highlights the Fitzroy study and results: "There are several
strengths in this well-designed trial. The use of a number of
clinical, endoscopic, and biochemical endpoints ensures robustness
of benefit of treatment and provides strong support for further
investigation of this therapeutic mechanism. The requirement of
endoscopically active disease at randomization and use of central
readers to adjudicate eligibility and efficacy increased the
clarity in the efficacy signal and reduced the potential of bias,"
said Dr Ashwin Ananthakrishnan in this editorial commentary in the
same issue of The Lancet.
Galapagos and Gilead entered into a global
collaboration for the development and commercialization of
filgotinib in inflammatory indications. Gilead initiated the FINCH
Phase 3 study in rheumatoid arthritis in August, the DIVERSITY
Phase 3 study in CD in November and the SELECTION Phase 2b/3
program in ulcerative colitis earlier this month.
Filgotinib is an investigational drug and its
efficacy and safety have not been established.
About the FITZROY study and resultsThe
FITZROY Phase 2 study (174 patients) evaluated filgotinib
once-daily versus placebo in patients with moderately to severely
active Crohn's disease and mucosal ulceration. Patients recruited
were either anti-TNF naïve or anti-TNF failures. The study
comprised two parts, each of 10 weeks duration: the first part
investigated the safety and efficacy of filgotinib 200 mg once
daily versus placebo, while the second part of the study
investigated continued treatment through 20 weeks in an
observational exploratory design. The FITZROY study achieved the
primary endpoint of clinical remission at 10 weeks: the percentage
of patients achieving a Crohn's Disease Activity Index (CDAI) score
below 150 was significantly higher in patients treated with
filgotinib versus patients receiving placebo. Improvement in
quality of life, histopathology, endoscopy assessment and
biomarkers of inflammatory activity were also observed at Week 10.
Clinical responses were maintained from week 10 to week 20.
Non-responders in the placebo arm from the first 10 weeks received
filgotinib 100 mg in the second 10 weeks and showed improvement in
clinical remission during the second part of the study.
Overall, in the FITZROY study at 20 weeks of
treatment, filgotinib demonstrated a favorable safety profile
consistent with the previous DARWIN studies in RA. An increase in
hemoglobin was also observed in FITZROY, without difference between
filgotinib and placebo. No clinically significant changes from
baseline in neutrophils or liver function tests were observed.
For information about the studies with
filgotinib in IBD: www.clinicaltrials.govFor more information about
filgotinib: www.glpg.com/filgotinib
About GalapagosGalapagos (Euronext & NASDAQ: GLPG) is
a clinical-stage biotechnology company specialized in the discovery
and development of small molecule medicines with novel modes of
action. Our pipeline comprises a pipeline of Phase 3, Phase 2,
Phase 1, pre-clinical, and discovery programs in cystic fibrosis,
inflammation, fibrosis, osteoarthritis and other indications. We
have discovered and developed filgotinib: in collaboration with
Gilead we aim to bring this JAK1-selective inhibitor for
inflammatory indications to patients all over the world. Galapagos
is focused on the development and commercialization of novel
medicines that will improve people's lives. The Galapagos group,
including fee-for-service subsidiary Fidelta, has approximately 480
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contacts
Investors: |
Media: |
Elizabeth Goodwin |
Evelyn
Fox |
VP IR
& CorporateCommunications+1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van
der HorstDirector IR & BusinessDevelopment+31 6 53 725 199 |
|
ir@glpg.com |
|
Forward-looking statementsThis release may contain
forward-looking statements, including statements regarding the
potential activity of filgotinib, the anticipated timing of
clinical studies with filgotinib, and the progression and results
of such studies. Galapagos cautions the reader that forward-looking
statements are not guarantees of future performance.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos'
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are the inherent 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 in rheumatoid arthritis, Crohn's disease and/or ulcerative
colitis may not support registration or further development of
filgotinib due to safety, efficacy or other reasons), Galapagos'
reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), and estimating the
commercial potential of Galapagos' product candidates. A further
list and description of these risks, uncertainties and other risks
can be found in Galapagos' Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos' most recent annual
report on form 20-F filed with the SEC and subsequent filings and
reports filed by Galapagos with the SEC. Given these uncertainties,
the reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak
only as of the date of publication of this document. Galapagos
expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/94a46aea-f88f-4536-955b-7e05be546780
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Apr 2023 to Apr 2024