Galapagos completes recruitment for Darwin 1 study with GLPG0634 (filgotinib) in RA
(Thomson Reuters ONE) -
Mechelen, Belgium 12 November 2014: Galapagos NV (Euronext: GLPG), a clinical
stage biotech company focused on developing novel mode of action medicines,
announces that recruitment of rheumatoid arthritis (RA) patients for the Darwin
1 Phase 2B study with GLPG0634 has been completed.
Selective JAK1 inhibitor GLPG0634 (filgotinib) has shown a best-in-class profile
in two 4-week Phase 2A studies in RA patients. GLPG0634 is currently in a
global Phase 2B program (DARWIN) in 875 RA patients and in a Phase 2 study in
180 patients with Crohn's disease.
DARWIN 1 plans to enroll 595 patients with moderate to severe rheumatoid
arthritis who insufficiently respond to methotrexate but remain on their
background therapy of methotrexate. DARWIN 1 is a double-blind, placebo-
controlled evaluation of three doses of GLPG0634, as once- and twice-daily
administration. Following the closure of recruitment, the last patient will now
be randomized in the study before the end of the month. Topline, blinded
results from the first 12 weeks of treatment in DARWIN 1 are expected around the
end of Q1 2015, with topline 24 weeks results expected three months later.
DARWIN 2 plans to enroll 280 patients with moderate to severe rheumatoid
arthritis who insufficiently respond to methotrexate. DARWIN 2 is a double-
blind, placebo-controlled investigation of three once-daily dose levels of
GLPG0634 as monotherapy treatment. Completion of recruitment for DARWIN 2 is
expected in the coming weeks. Topline results from 12 week results are expected
in Q2 2015, with complete 24 week data package expected in Q3 2015. AbbVie will
base its licensing decision on the complete 24 week DARWIN 1 and 2 data packages
from GLPG0634.
Dr Piet Wigerinck, Chief Scientific Officer of Galapagos, commented: "We are
pleased that recruitment for Darwin 1 has been completed and that Darwin 2 is on
track to complete recruitment in the coming weeks. We see a good spread of
patients coming in across the major geographic areas and continue to see more
than 90% of patients who complete the DARWIN 1 and 2 studies enroll in the
DARWIN 3 long-term extension study. We are encouraged by this roll-over rate,
and we look forward to seeing all the results next year."
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a pipeline comprising three Phase 2 studies, two Phase 1 studies, five pre-
clinical, and 20 discovery small-molecule and antibody programs in cystic
fibrosis, inflammation, antibiotics and metabolic disease. In the field of
inflammation, AbbVie and Galapagos signed an agreement for the development and
commercialization of GLPG0634. GLPG0634 is an orally-available, selective
inhibitor of JAK1 for the treatment of rheumatoid arthritis and other
inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in
Crohn's disease. Galapagos has another selective JAK1 inhibitor, GSK2586184
(formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). AbbVie and
Galapagos signed an agreement in cystic fibrosis to develop and commercialize
molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is
expected to start Phase 1 in 2014. Galapagos also expects to nominate a pre-
clinical candidate corrector before year end 2014. The Galapagos Group,
including fee-for-service subsidiary Fidelta, has around 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(at)glpg.com
Galapagos forward-looking statements
This release may contain forward-looking statements, including, without
limitation, statements containing the words "believes," "anticipates,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will," "could,"
"stands to," and "continues," 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. 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.
This announcement is distributed by GlobeNewswire on behalf of
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originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
[HUG#1870603]
Unternehmensinformation / Kurzprofil:
Datum: 12.11.2014 - 07:31 Uhr
Sprache: Deutsch
News-ID 351671
Anzahl Zeichen: 6114
contact information:
Town:
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Kategorie:
Business News
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