MECHELEN, BELGIUM--(Marketwire -06/05/12)- Galapagos NV (GLPGF)announced todaythat it will give an oral presentation on 9 June 2012 at the EULARAnnualEuropean Congress of Rheumatology. Galapagos will present the resultsfrom thePhase II Proof of Concept study for GLPG0634, a selective inhibitor ofJanuskinase 1 (JAK1), in rheumatoid arthritis patients.
The Proof of Concept results for GLPG0634 will be presented Saturdayat TheEuropean League Against Rheumatism (EULAR) taking place 6 to 9 June2012 inBerlin:
Efficacy and Safety of GLPG0634, a Selective JAK1 Inhibitor, afterShort-termTreatment 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 rapidonsetof action and a very good safety profile when given for 28 days to patientswithmoderate to severe rheumatoid arthritis, insufficientlycontrolled bymethotrexate alone.
The full abstract can be accessed through the EULAR conferencewebsite:www.eular.org
Details of the Phase II clinical study
The clinical Proof of Concept Phase II study for GLPG0634 involved 36patientswith active rheumatoid arthritis, showing an insufficient responseto thestandard-of-care treatment, methotrexate (MTX). The aim of this studywas toevaluate the efficacy and safety of GLPG0634 in patients with activerheumatoidarthritis. Three groups of 12 patients with moderate to severe diseasereceivedeither a 200 mg once-daily or a 100 mg twice-daily dose regimen ofGLPG0634 orplacebo, for a period of four weeks, while continuing to take theirstablebackground therapy of MTX and other low-dose anti-inflammatory drugs.Theprimary efficacy endpoint was the ACR20 response rate, the standardprimaryendpoint for early RA clinical studies. Secondary endpointsincludedimprovements in ACR50, ACR70 and DAS28 rates. The safety,tolerability,pharmacokinetics and pharmacodynamics of GLPG0634 in RA patients werealsoevaluated.
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitorwithselectivity for JAK1 developed by Galapagos. JAKs are criticalcomponents ofsignaling mechanisms utilized by a number of cytokines and growthfactors,including those that are elevated in rheumatoid arthritis patients.JAKinhibitors have shown long-term efficacy in rheumatoid arthritis studieswith anearly onset of action. GLPG0634 differentiates from other JAKinhibitors indevelopment by specifically targeting JAK1, a strategy which could resultin abetter efficacy and safety profile. GLPG0634 is a fully proprietaryprogram. Upon successful completion of the RA Phase IIb studies, Abbott willlicense theprogram and will assume sole responsibility for Phase III clinicaldevelopmentand global manufacturing.
The annual EULAR congresses are a major event in the calendar ofworldrheumatology. The aim is to provide a forum of the higheststandard forscientific (both clinical and basic), educational and social exchangebetweenprofessionals involved in rheumatology, liaising with patientorganisations, inorder to achieve progress in the clinical care of patients withrheumaticdiseases. More info at: www.eular.org
Galapagos (GLPGF) (GLPYY) is a mid-sizebiotechnology companyspecialized in the discovery and development of small molecule andantibodytherapies with novel modes-of-action. The Company is progressingGLPG0634, aswell as one of the largest pipelines in biotech, with fourprograms indevelopment and over 50 discovery programs. The Galapagos Group has about800employees and operates facilities in six countries, with globalheadquarters inMechelen, Belgium. More info at: www.glpg.com
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