Galapagos initiates Phase IIa study with GLPG0634
(Thomson Reuters ONE) -
* Selective JAK1 profile differentiates from other compounds in development
* Follows successful outcome of Proof of Concept study in rheumatoid arthritis
patients
* Phase IIa study designed to assess efficacy and safety in rheumatoid
arthritis patients over wide dose range and in multiple countries by the end
of 2012
Mechelen, Belgium; 14 May 2012 - Galapagos NV (Euronext: GLPG) announced today
that it has started its second Phase IIa clinical study with GLPG0634, a novel
Janus kinase 1 (JAK1) inhibitor being developed to treat multiple autoimmune
diseases, such as rheumatoid arthritis (RA). In this clinical study, the
efficacy and safety of GLPG0634 will be evaluated for four weeks in RA patients,
with completion planned by the end of 2012.
"The promising results from our Proof of Concept study clearly differentiate
GLPG0634 from other JAK inhibitors in development in RA, both in terms of
efficacy and safety. With the start of a broader Phase IIa study, we look
forward to gathering dose-range finding data from 90 patients across multiple
countries, adding to our understanding of the candidate drug's differentiation,"
said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "Meanwhile, the
expansion of our development team is progressing on track, as we also prepare
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 rheumatoid
arthritis, showing an insufficient response to the standard-of-care treatment,
methotrexate (MTX). The aim is to evaluate the efficacy, safety, tolerability
and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in treating
rheumatoid arthritis. Five groups of 18 patients with active disease will take
the once-daily 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 early response in RA clinical studies. Secondary endpoints include
improvements in DAS28, ACR50 and ACR70 rates. Galapagos has received approvals
to start the study in multiple sites across 4 different countries (Hungary,
Moldova, Russia, and Ukraine), with patient recruitment currently underway. The
study has been designed and is anticipated to deliver data by the end of 2012.
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 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, SVP Development
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.
--------------------------------------------------------------------------------
[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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Source: Galapagos NV via Thomson Reuters ONE
[HUG#1611614]
Unternehmensinformation / Kurzprofil:
Datum: 14.05.2012 - 07:30 Uhr
Sprache: Deutsch
News-ID 145769
Anzahl Zeichen: 6780
contact information:
Town:
Mechelen
Kategorie:
Business News
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