MECHELEN, BELGIUM--(Marketwire - May 14, 2012) -
* Selective JAK1 profile differentiates from other compounds in
* Follows successful outcome of Proof of Concept study in rheumatoid
* Phase IIa study designed to assess efficacy and safety in rheumatoid
arthritis patients over wide dose range and in multiple countries by the
Galapagos NV (Euronext: GLPG) announced today
that it has started its second Phase IIa clinical study with GLPG0634, a
Janus kinase 1 (JAK1) inhibitor being developed to treat multiple
diseases, such as rheumatoid arthritis (RA). In this clinical
efficacy and safety of GLPG0634 will be evaluated for four weeks in RA
with completion planned by the end of 2012.
"The promising results from our Proof of Concept study clearly
GLPG0634 from other JAK inhibitors in development in RA, both in
efficacy and safety. With the start of a broader Phase IIa study, we
forward to gathering dose-range finding data from 90 patients across
countries, adding to our understanding of the candidate drug's
said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.
expansion of our development team is progressing on track, as we also
for the global Phase IIb study that should start next year."
Details of the Phase IIa clinical study
The Phase IIa study for GLPG0634 will enroll 90 patients with active
arthritis, showing an insufficient response to the standard-of-care
methotrexate (MTX). The aim is to evaluate the efficacy, safety,
and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in
rheumatoid arthritis. Five groups of 18 patients with active disease will
the once-daily regimen of GLPG0634 or placebo for a period of four weeks,
all will continue to take their stable background therapy of MTX. The
efficacy endpoint will be the ACR20 response rate, the standard
endpoint for early response in RA clinical studies. Secondary endpoints
improvements in DAS28, ACR50 and ACR70 rates. Galapagos has received
to start the study in multiple sites across 4 different countries
Moldova, Russia, and Ukraine), with patient recruitment currently underway.
study has been designed and is anticipated to deliver data by the end of
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor
selectivity for JAK1 developed by Galapagos. JAKs are critical
signaling mechanisms utilized by a number of cytokines and growth
including those that are elevated in rheumatoid arthritis patients.
inhibitors have shown long-term efficacy in rheumatoid arthritis studies
early onset of action. GLPG0634 differentiates from other JAK
development by specifically targeting JAK1, a strategy which could result
better efficacy and safety profile. GLPG0634 is a fully proprietary
Upon successful completion of the RA Phase IIb studies, Abbott will
program and will assume sole responsibility for Phase III clinical
and global manufacturing.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology
specialized in the discovery and development of small molecule and
therapies with novel modes-of-action. The Company is progressing
well as one of the largest pipelines in biotech, with four
development and over 50 discovery programs. The Galapagos Group has about
employees and operates facilities in six countries, with global
Mechelen, Belgium. More info at: www.glpg.com
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required by law or regulation.
 ACR20 (American College of Rheumatology 20%) response rate signifies a
greater improvement in the number of swollen and tender joints as well as a
improvement in three out of five other disease-activity measures.
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