Home » Business News » 2013 » June » June 13, 2013

Galapagos presents GLPG0634 at EULAR poster session

June 13, 2013 - Mechelen, Belgium

Posters now available online at www.glpg.comQ&A session with Galapagos CSO today at 15.00 CET/9 AM EDT/6 AM PT, callnumbers for the teleconference call: US 480-629-9645, Toll-free 877-941-60;Belgium 2290-1608, Toll-free 0800-50747; Netherlands 20 794 8504,Toll-free 0800-265-8528

Galapagos NV (EURONEXT BRUSSELS: GLPG) is presentingthree posters on its selective JAK1 inhibitor GLPG0634 at the EuropeanLeagueAgainst Rheumatism (EULAR) Annual Congress taking place this week inMadrid,Spain. The posters are available online at

Chief Scientific Officer Dr Piet Wigerinck will answer questionsabout theposters in a teleconference call at 15.00 CET/9 am EDT/6 am PT, callnumbers US480-629-9645, Toll-free 877-941-60; Belgium 2290-1608, Toll-free0800-50747; Netherlands 20 794 8504, Toll-free 0800-265-8528. Arecordingof the teleconference call will be archived on Galapagos' website.

Following is an overview of the posters, with key conclusions:

Safety and efficacy of GLPG0634, a selective JAK1 inhibitor, in patientswithrheumatoid arthritis: results of a 4-week Phase IIA dose ranging,multi-center trial

Selective inhibition of JAK1 by once-daily dosing of GLPG0634 from 75 -300 mgwas well tolerated and efficacious in this 4-week study. A favourablesafetyprofile was observed, with an absence of the typical findings reported forotherJAK inhibitors. GLPG0634 caused no anemia, no overall change to LDL orALT, andno neutropenia. Regarding efficacy, a dose trend for improvement in RAdiseaseparameters was found: 30 mg QD was sub-optimal, while doses of 75, 150 and300mg showed promising efficacy, with similar response rates in CRP, TJC,SJC andDAS28.

An imbalance in baseline characteristics of two patient groups mayhaveinfluenced the study outcome:

· the placebo group showed a relatively high response ratecorrelating witha short history of RA

· the 150 mg group was most severely diseased. The 150 mggroup showed arobust response in CRP, TJC, and SJC. However, the 4-week duration of thetrialwas too short to reach the full potential on patient-reported scores(painassessment, global assessment, HAQ-DI).

The encouraging short term efficacy and favourable safety profile in thisstudysupports the potential of selective inhibition of JAK1 as a future RAtreatmentoption, and confirms data from a previous Proof of Concept study at a200 mgdaily dose.

Once-daily dosing of GLPG0634, a selective JAK1 inhibitor, is supportedby itsactive metabolite

An active and JAK1-selective metabolite supports the activity of GLPG0634.Thelower potency of the metabolite is compensated by its high exposure inhumans. The long half-life of the metabolite and the resulting high plasma levelswhenparent GLPG0634 is at trough, provides a lasting effect. Because of the7-hour half-life of GLPG0634, both BID and QD regimens were studied.However, themetabolite contribution to JAK1 inhibition now provides a potentialexplanationfor the sustained efficacy results observed with once daily dosing ofGLPG0634,adding to convenience for patients.

Biological effects of the JAK1 selective inhibitor GLPG0634 oninflammationmarkers in arthritic mice

Oral administration of the selective JAK1 inhibitor GLPG0634 in arthriticmicedemonstrates a selective engagement of the JAK1 target by GLPG0634 invivo. Progression of established arthritis in the CIA model is blocked byselectiveinhibition of JAK1. GLPG0634 administration inhibits inflammation andconfersstructural protection at the level of bone and cartilage in atherapeutic CIAmodel. A single administration of GLPG0634 is sufficient to blockCIA-induced inflammatory signalling.

About candidate drug GLPG0634

GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitorwithselectivity for JAK1 developed by Galapagos. JAKs are criticalcomponents ofsignalling 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 Phase 2b studies in RA, AbbVie willlicensethe program and will assume sole responsibility for Phase 3 clinicaldevelopmentand global manufacturing. Furthermore, AbbVie and Galapagos recentlyannouncedthe initiation of a Phase 2 study with GLPG0634 in Crohn's Disease.


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:

About Galapagos

Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novelmodes-of-action, with a large pipeline of four clinical, sevenpre-clinical, and 30 discovery small-molecule and antibody programsin cystic fibrosis, inflammation,antibiotics, metabolic disease, and other indications.

GLPG0634 is an orally-available, selective inhibitor of JAK1 for thetreatmentof rheumatoid arthritis and potentially other inflammatory diseases,currentlyin Phase 2b studies in RA and about to enter Phase 2 studies inCrohn'sdisease. AbbVie and Galapagos signed a worldwide license agreementwherebyAbbVie will be responsible for further development and commercializationafterPhase 2b. Galapagos has another selective JAK1 inhibitor in Phase 2 inlupusand psoriasis, GSK2586184 (formerly GLPG0778, in-licensed byGlaxoSmithKline in2012). GLPG0187 is a novel integrin receptor antagonist currently in aPhase1b patient study in metastasis. GLPG0974 is the first inhibitor of GPR43to beevaluated clinically for the treatment of IBD; this program is currentlyin aProof of Concept Phase 2 study.

The Galapagos Group, including fee-for-service companies BioFocus,Argenta andFidelta, has 800 employees and operates facilities in five countries,withglobal headquarters in Mechelen, Belgium. Further information

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.

Galapagos presents GLPG0634 at EULAR poster session:

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



Galapagos NV
Piet Wigerinck
Tel: 477 62 7103

Elizabeth Goodwin
Director Investor Relations
Tel: 6 2291 6240
Email Contact


Comment on this story