Endoscopic improvements with filgotinib are consistent with clinical remission rates in patients with Crohn's disease
September 25 2016 - 8:20PM
Galapagos NV (Euronext & NASDAQ: GLPG) reports that Dr
Severine Vermeire, principal investigator of the FITZROY Phase 2
study with investigational agent filgotinib in Crohn's disease,
will present endoscopic and other key findings from the study in an
oral session during United European Gastroenterology Week (UEG
Week) in Vienna, Oct. 15 - 19, 2016. The abstract for the talk is
available online at www.ueg.eu/week/
.
The FITZROY Phase 2 study randomized 174
patients with Crohn's disease. Across the study, the average
baseline CDAI score was 293, with average baseline SES-CD score of
14.6.
Variable/unit/population |
placebo n=44 |
filgotinib n=128 |
p-value |
Clinical remission (CDAI<150), %, ITT-NRI |
23 |
47 |
0.0077 |
SES-CD improvement by at least 50%, %, ITT-LOCF |
13.6 |
25 |
NS |
Overall total histopathology score, mean change from baseline,
ITT-LOCF |
-0.6 |
-3.5 |
0.0359 |
CDAI: Crohn's disease activity index; ITT: intent-to-treat; NRI:
non-responder imputation; LOCF: last observation carried forward;
SES-CD: simple endoscopic score for Crohn's disease; Histopathology
score = Adaptation from histopathology score D'haens. Note that the
FITZROY study was not powered for statistical significance on
endoscopy.
"The endoscopic improvement and the
histopathological benefit are additional strong and relevant
indicators contributing to the potential of filgotinib as an oral
treatment for Crohn's patients," said Dr Severine Vermeire,
principal investigator of the FITZROY study.
Overall, filgotinib was safe and well tolerated.
Similar incidences in early discontinuations, SAEs and AEs
including infections were observed, with the majority of the SAEs
related to worsening of CD. An increase in mean hemoglobin
concentration was observed, without difference between filgotinib
and placebo. No clinically significant changes from baseline in
mean neutrophil counts or liver function tests were observed.
Filgotinib showed a favorable lipid profile with an increase in HDL
and no change in LDL, resulting in an improved atherogenic
index.
"This is the first known double-blind,
placebo-controlled study in Crohn's disease with endoscopic central
reading as an inclusion criterion and as efficacy endpoint," said
Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.
"Galapagos chose a 50% improvement in SES-CD scores as the
appropriate hurdle for a potential new therapy option in Crohn's
disease, and we are very pleased that endoscopic improvement was in
line with observed clinical remission and response rates, CRP
improvements, and patient reported outcomes."
Dr Vermeire will speak at UEG Week on 17 October
2016, at 16.20 CET, in the session entitled "Future drugs in IBD,"
abstract OP105, entitled: "Filgotinib, a selective JAK1 inhibitor,
induces clinical remission in patients with moderate-to-severe
Crohn's disease: final analysis of the Phase 2 FITZROY study."
Galapagos and Gilead entered into a global
collaboration for the development and commercialization of
filgotinib for inflammatory indications. Gilead initiated the FINCH
Phase 3 program in rheumatoid arthritis in August 2016 and expects
to initiate a Phase 3 study in Crohn's disease and a Phase 2/3
study in ulcerative colitis in Q4 2016.
Filgotinib is an investigational therapy and its
efficacy and safety have not been established.
For more information about filgotinib:
www.glpg.com/filgotinib
For more information about UEG Week:
www.ueg.eu/week/
Conference call
Galapagos will conduct a conference call open to
the public on 26 September 2016 at 14:00 Central European Time
(CET), 8 AM ET. To participate in the conference call, please call
one of the following numbers ten minutes prior to commencement:
CODE: 8889838
USA: |
+1 719 457 2086 |
UK: |
+44 330 336 9411 |
Netherlands: |
+31 20 703 8261 |
France: |
+33 1 76 77 22 57 |
Belgium: |
+32 2 400 6926 |
An archived recording will also be available for
replay shortly after the close of the call.
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 maturing 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 460 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 Communications |
Director
Communications |
+1 781
460 1784 Paul van der Horst Director IR & Business
Development +31 6 53 725 199 |
+31 6 53 591 999
communications@glpg.com |
ir@glpg.com |
|
Forward-Looking Statements
This release may contain
forward-looking statements, including statements regarding any
guidance given by Galapagos' management, the anticipated timing of
clinical studies with filgotinib, the progression and results of
such studies and ongoing interactions with regulatory authorities.
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
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only as of the date of publication of this document. Galapagos
expressly disclaims any obligation to update any such
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in its expectations with regard thereto or any change in events,
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that may affect the likelihood that actual results will differ from
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