Galapagos reports that the last patient in DARWIN 1 has completed 12 weeks of treatment
February 23 2015 - 1:36AM
- Last of 599 enrolled rheumatoid arthritis patients has
completed the 12 week visit with filgotinib (GLPG0634) or
placebo
- Triggers start of final 12 week data collection, followed by
completion of data verification and data analysis
- Topline 12 week results expected to be released by mid-April
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.
HUG#1896325
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