Galapagos reports that the last patient in DARWIN 1 has completed 12 weeks of treatment
23 Febrero 2015 - 12:30AM
-
Last of 599 enrolled rheumatoid
arthritis patients has completed the 12 week visit with filgotinib
(GLPG0634) or placebo
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Triggers start of final 12 week
data collection, followed by completion of data verification and
data analysis
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Topline 12 week results
expected to be released by mid-April 2015
Mechelen,
Belgium; 23 February 2015 - Galapagos NV (Euronext: GLPG),
a clinical stage biotechnology company focused on
developing novel mode of action medicines, announces that the last
patient in the DARWIN 1 trial with filgotinib has completed the 12
week visit. This last patient's 12 week visit triggers the
clinical research organization's process of final 12 week data
collection from all 599 patients enrolled in the trial, to be
followed by database lock and analysis. As this process takes
approximately 7 to 8 weeks, Galapagos expects to announce topline
results by mid-April 2015.
Selective JAK1 inhibitor
filgotinib has demonstrated a potential best-in-class profile in
two 4-week Phase 2A trials in RA patients. Filgotinib is
currently in a global Phase 2B program (DARWIN 1, 2 and 3) in 886
RA patients and in a Phase 2 trial in 180 patients with Crohn's
disease.
DARWIN 1 is a 24 week
double-blind, placebo-controlled trial that enrolled 599 patients
with moderate to severe rheumatoid arthritis who inadequately
responded to methotrexate; all patients remain on their background
therapy of methotrexate. This trial evaluates three doses of
filgotinib, as once- and twice-daily administration. In
mid-April Galapagos expects to report topline results on the first
12 weeks of treatment, whereas the trial continues for an
additional 12 weeks of treatment. Topline data from 24 weeks'
treatment in DARWIN 1 is expected in July 2015.
Topline results from 12 weeks'
treatment in DARWIN 1 will include unblinded ACR20 (primary
endpoint) scores and other significant secondary endpoints, as well
as important lab and safety information. Frequency of rare
events, including severe adverse events, will be disclosed but will
remain blinded until disclosure of the 24 week treatment topline
data, to ensure the double-blind character of the DARWIN program.
"We look forward to the 12 week
topline results of DARWIN 1 in mid-April," said Dr Piet Wigerinck,
Chief Scientific Officer of Galapagos. "We see 98% of eligible
patients who complete DARWIN 1 and 2 enrolling in DARWIN 3, with
400 patients now in the long term extension study. The fact
that investigators and patients see benefit in continuing treatment
with filgotinib gives confidence."
About data
management
Data management is a labor-intensive key step in clinical trials
such as DARWIN. It is highly regulated since the data
collected will be used for statistical analysis and report writing
and will subsequently be subject to regulatory review. The
data must reflect the medical records of the patients in the study,
the source data as collected and stored at the study site.
Therefore, the data collected on case report forms will be verified
with the records in the hospitals, worldwide. All the data
collected will be checked for missing, outlying or inconsistent
values. When the data are complete and fully verified, the
database is locked, such that data can no longer be changed.
Only after this, the data analysis and statistical evaluation
can start. This will finally lead to a set of analyzed data
and a statistical analysis report.
About
Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a clinical-stage
biotechnology company specialized in the discovery and development
of small molecule medicines with novel modes of action, with a
pipeline comprising three Phase 2 programs, two Phase 1 trials,
five pre-clinical studies, and 25 discovery small-molecule and
antibody programs in cystic fibrosis, inflammation, and other
indications. In the field of inflammation, AbbVie and
Galapagos signed a collaboration agreement for the development and
commercialization of filgotinib. Filgotinib is an
orally-available, selective inhibitor of JAK1 for the treatment of
rheumatoid arthritis and potentially other inflammatory diseases,
currently in Phase 2b studies in RA and in Phase 2 in Crohn's
disease. GLPG1205, a first-in-class inhibitor of GPR84, is
currently being tested in a Phase 2 proof-of-concept trial in
ulcerative colitis patients. GLPG1690 is a compound that
targets pulmonary diseases and is currently in a Phase 1
trial. AbbVie and Galapagos also signed a collaboration
agreement in cystic fibrosis to develop and commercialize molecules
that address mutations in the CFTR gene. Potentiator GLPG1837
is currently in a Phase 1 trial, and corrector GLPG2222 is at the
pre-clinical candidate stage. The Galapagos Group, including
fee-for-service subsidiary Fidelta, has approximately 400
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. Further
information at: www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications &
IR
Tel: +31 6 2291 6240
ir@glpg.com
Galapagos forward-looking
statements
This release may contain forward-looking
statements, including, without limitation, statements concerning
the safety and efficacy of filgotinib and the expected timing of
the release of topline 12-week results from the DARWIN trials and
the expected timing and announcement of topline 24-week results
from the DARWIN trials, expectations regarding the commercial
potential of our product candidates generally, all of which involve
certain risks and uncertainties. These statements are often, but
are not always, made through the use of words or phrases such as
"believes," "anticipates," "expects," "intends," "plans," "seeks,"
"estimates," "may," "will," "could," "stands to," "continues," "we
believe," "we intend," as well as similar expressions. Such
forward-looking statements may involve known and unknown risks,
uncertainties and other factors which might cause the actual
results, financial condition, performance or achievements of
Galapagos, or industry results, to be materially different from any
historic or future results, financial conditions, performance or
achievements expressed or implied by such forward-looking
statements. Among the factors that may result in differences are
the inherent uncertainties associated with competitive
developments, clinical trial and product development activities,
regulatory approval requirements and estimating the commercial
potential of our product candidates. 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,
unless required by law or regulation.
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announcement is distributed by NASDAQ OMX Corporate Solutions on
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The issuer of this announcement warrants that they are solely
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Source: Galapagos NV via Globenewswire
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