The Lancet publishes FITZROY study results with filgotinib in Crohn's disease
(Thomson Reuters ONE) -
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 results
The 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.gov
For more information about filgotinib: www.glpg.com/filgotinib
About Galapagos
Galapagos (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 & Corporate Director Communications
Communications +31 6 53 591 999
+1 781 460 1784 communications(at)glpg.com
Paul van der Horst
Director IR & Business
Development
+31 6 53 725 199
ir(at)glpg.com
Forward-looking statements
This 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.
Filgotinib inThe Lancet:
http://hugin.info/133350/R/2065498/775373.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
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