Galapagos to present GLPG0634 Phase II POC results at EULAR

Marketwired

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.

About EULAR

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

About Galapagos

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

This release may contain forward-looking statements, including,withoutlimitation, statements containing the words "believes,""anticipates,""expects," "intends," "plans," "seeks," "estimates," "may," "will,""could,""stands to," and "continues," as well as similar expressions. Suchforward-looking statements may involve known and unknown risks,uncertainties and otherfactors which might cause the actual results, financial condition,performanceor achievements of Galapagos, or industry results, to be materiallydifferentfrom any historic or future results, financial conditions,performance orachievements expressed or implied by such forward-looking statements.Giventhese uncertainties, the reader is advised not to place any unduereliance onsuch forward-looking statements. These forward-looking statements speakonly asof the date of publication of this document. Galapagos expresslydisclaims anyobligation to update any such forward-looking statements in thisdocument toreflect any change in its expectations with regard thereto or anychange inevents, conditions or circumstances on which any such statement is based,unlessrequired by law or regulation.

This announcement is distributed by Thomson Reuters on behalf ofThomson 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]

Contact:
CONTACT
Galapagos NV
Piet Wigerinck
CSO
Tel: +32 477 62 7103
Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
Email Contact

Rates

View Comments (0)