MECHELEN, BELGIUM--(Marketwire - June 05, 2012) - Galapagos NV (EURONEXT BRUSSELS: 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 BRUSSELS: GLPG) (PINKSHEETS: 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
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 Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Galapagos NV via Thomson Reuters ONE
[HUG#1617319]
