Galapagos to present GLPG0634 Phase II POC results at EULAR
(Thomson Reuters ONE) -
Mechelen, Belgium; 5 June 2012 - Galapagos NV (Euronext: GLPG) announced today
that it will give an oral presentation on 9 June 2012 at the EULAR Annual
European Congress of Rheumatology. Galapagos will present the results from the
Phase II Proof of Concept study for GLPG0634, a selective inhibitor of Janus
kinase 1 (JAK1), in rheumatoid arthritis patients.
The Proof of Concept results for GLPG0634 will be presented Saturday at The
European League Against Rheumatism (EULAR) taking place 6 to 9 June 2012 in
Berlin:
Efficacy and Safety of GLPG0634, a Selective JAK1 Inhibitor, after Short-term
Treatment of Rheumatoid Arthritis; Results of a Phase IIa Trial (9 June, 9:50 -
10:00 AM, Hall 1.1)
The presented data demonstrate that GLPG0634 is highly active with a rapid onset
of action and a very good safety profile when given for 28 days to patients with
moderate to severe rheumatoid arthritis, insufficiently controlled by
methotrexate alone.
The full abstract can be accessed through the EULAR conference website:
www.eular.org
Details of the Phase II clinical study
The clinical Proof of Concept Phase II study for GLPG0634 involved 36 patients
with active rheumatoid arthritis, showing an insufficient response to the
standard-of-care treatment, methotrexate (MTX). The aim of this study was to
evaluate the efficacy and safety of GLPG0634 in patients with active rheumatoid
arthritis. Three groups of 12 patients with moderate to severe disease received
either a 200 mg once-daily or a 100 mg twice-daily dose regimen of GLPG0634 or
placebo, for a period of four weeks, while continuing to take their stable
background therapy of MTX and other low-dose anti-inflammatory drugs. The
primary efficacy endpoint was the ACR20 response rate, the standard primary
endpoint for early RA clinical studies. Secondary endpoints included
improvements in ACR50, ACR70 and DAS28 rates. The safety, tolerability,
pharmacokinetics and pharmacodynamics of GLPG0634 in RA patients were also
evaluated.
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with
selectivity for JAK1 developed by Galapagos. JAKs are critical components of
signaling mechanisms utilized by a number of cytokines and growth factors,
including those that are elevated in rheumatoid arthritis patients. JAK
inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an
early onset of action. GLPG0634 differentiates from other JAK inhibitors in
development by specifically targeting JAK1, a strategy which could result in a
better efficacy and safety profile. GLPG0634 is a fully proprietary program.
Upon successful completion of the RA Phase IIb studies, Abbott will license the
program and will assume sole responsibility for Phase III clinical development
and global manufacturing.
About EULAR
The annual EULAR congresses are a major event in the calendar of world
rheumatology. The aim is to provide a forum of the highest standard for
scientific (both clinical and basic), educational and social exchange between
professionals involved in rheumatology, liaising with patient organisations, in
order to achieve progress in the clinical care of patients with rheumatic
diseases. More info at: www.eular.org
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company
specialized in the discovery and development of small molecule and antibody
therapies with novel modes-of-action. The Company is progressing GLPG0634, as
well as one of the largest pipelines in biotech, with four programs in
development and over 50 discovery programs. The Galapagos Group has about 800
employees and operates facilities in six countries, with global headquarters in
Mechelen, Belgium. More info at: www.glpg.com
CONTACT
Galapagos NV
Piet Wigerinck, CSO
Tel: +32 477 62 7103
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)glpg.com
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.
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Source: Galapagos NV via Thomson Reuters ONE
[HUG#1617319]
Unternehmensinformation / Kurzprofil:
Datum: 05.06.2012 - 07:31 Uhr
Sprache: Deutsch
News-ID 152938
Anzahl Zeichen: 6505
contact information:
Town:
Mechelen
Kategorie:
Business News
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