Galapagos initiates Phase II trial for GLPG0634
(Thomson Reuters ONE) -
* Follows successful outcome of Phase I trials
* Proof-of-Concept study designed to assess efficacy in rheumatoid arthritis
patients by year end
* Selective JAK1 profile could differentiate from other compounds in
development
Mechelen, Belgium; 9 June 2011- Galapagos NV (Euronext: GLPG) announced today
that it has started a Phase II clinical study for GLPG0634, a novel Janus kinase
(JAK) inhibitor being developed for inflammatory conditions, such as rheumatoid
arthritis (RA). In this clinical trial, the efficacy and safety of GLPG0634
will be tested in RA patients, with plans to complete a four-week study by the
end of 2011. GLPG0634 is a fully proprietary program which Galapagos intends to
partner.
"We are pleased to initiate this Proof-of-Concept study for GLPG0634, which
marks our second patient trial in rheumatoid arthritis. The current study with
GLPG0634 is designed to show a fast onset of clinical response and will be
completed by the end of this year," said Piet Wigerinck, SVP Development. "The
pre-clinical and Phase I studies for this compound show a specific JAK1
inhibition profile, which could differentiate from other JAK compounds in
development."
Details of the Phase II clinical trial
The clinical Proof-of-Concept Phase II trial for GLPG0634 will involve 36
patients with active rheumatoid arthritis, showing an insufficient response to
the standard-of-care treatment, methotrexate (MTX). The aim is to evaluate the
efficacy and safety of GLPG0634 in treating rheumatoid arthritis. Three groups
of 12 patients with moderate to severe disease will receive either a once- or
twice-daily dose regimen of GLPG0634 or placebo, for a period of four weeks,
while all will continue to take their stable background therapy of MTX. The
primary efficacy endpoint will be the ACR20 response rate[1], the standard
primary endpoint for RA clinical trials. Secondary endpoints include
improvements in DAS28, ACR50 and ACR70 rates and clinical score. The safety and
tolerability, and the pharmacokinetics of GLPG0634 in rheumatoid arthritis
patients will also be evaluated. Galapagos has received approvals to start the
trial at a single Eastern European center, with patient recruitment planned to
start in June 2011. The trial has been designed to obtain initial efficacy data
by the end of 2011. This phase II trial is part of a broader development
program that includes additional pharmacology, Phase I, and preclinical toxicity
studies with GLPG0634. The additional studies with GLPG0634 will run in
parallel to the efficacy study started today, with the aim to prepare for
inclusion of additional dosage arms, should this maximize the potential value of
the Phase II study.
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 trials with an
early onset of action. Galapagos aims to differentiate GLPG0634 from other JAK
inhibitors in development by specifically targeting JAK1, a strategy which could
result in a cleaner safety profile.
GLPG0634 has demonstrated excellent activity in in vitro biochemical studies and
in vivo models of rheumatoid arthritis, and has successfully completed pre-
clinical development and Phase I studies in healthy volunteers.
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 one of the
largest pipelines in biotech, with six programs in development and over 50
discovery programs. Through risk/reward-sharing alliances with GlaxoSmithKline,
Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is eligible to
receive up to ?2.5 billion in downstream milestones, plus royalties. 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, SVP Development
Tel: +32 477 62 7103
Andre Hoekema, SVP Business Development (licensing)
Tel: +31 71 7506 727
andre.hoekema(at)glpg.com
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.
--------------------------------------------------------------------------------
[1] ACR20 (American College of Rheumatology 20%) response rate signifies a 20%
or greater improvement in the number of swollen and tender joints as well as a
20% improvement in three out of five other disease-activity measures.
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originality of the information contained therein.
Source: Galapagos NV via Thomson Reuters ONE
[HUG#1522311]
Unternehmensinformation / Kurzprofil:
Datum: 09.06.2011 - 07:32 Uhr
Sprache: Deutsch
News-ID 55429
Anzahl Zeichen: 7464
contact information:
Town:
Mechelen
Kategorie:
Business News
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