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Galapagos NV: First patients screened for Phase 2B studies with GLPG0634

July 1, 2013 - Mechelen, Belgium

* First rheumatoid arthritis patients screened in Belgium

* Galapagos on track with DARWIN Phase 2B program in rheumatoid arthritis

* 875 patients to be enrolled worldwide for 24 weeks of treatment

* Topline 12-week data from DARWIN 1 and DARWIN 2 available by end 2014

Galapagos NV (EURONEXT BRUSSELS: GLPG) announced todaythat the first rheumatoid arthritis (RA) patients have beenscreened forenrolment in the Phase 2B clinical program with GLPG0634, a selectiveJAK1inhibitor. The DARWIN Phase 2B program includes two dose finding studiesand anopen label extension study. The dose finding studies will evaluate theefficacyand safety of GLPG0634 with 24 weeks of treatment in 875 moderate tosevere RApatients refractory to methotrexate.

GLPG0634 is the first selective JAK1 inhibitor in development for RA.Theresults of two 4-week Phase 2A clinical studies demonstrated the rapidclinicalbenefit and favorable safety profile of the drug, and supported theselection ofthe GLPG0634 doses that will be evaluated in the current Phase 2Bprogram. Galapagos started the 24-week global DARWIN Phase 2B program in RA toidentifythe dose and dose-regimen that offers optimal efficacy and safety ofGLPG0634 inpatients with moderate to severe RA. Galapagos expects to reportcompletion ofrecruitment by mid-2014 and 12-week topline data from the Phase 2B programin Q42014.

"GLPG0634 has shown a rapid suppression of disease activity with a goodsafetyprofile in the 4-week Phase 2A studies in RA patients. We lookforward toseeing the effect of GLPG0634 in a global study, for a longer treatmentperiod,and in a larger and more diverse patient population. The first patientswill berecruited in Belgium and New Zealand," said Dr Piet Wigerinck, ChiefScientificOfficer of Galapagos. "Galapagos is on track in the RA program and is nowalsopreparing for a Phase 2 study with GLPG0634 in Crohn's disease, whichwill runin parallel with the Phase 2B study in RA. By early 2014, we will havePhase 2programs with GLPG0634 in RA and Crohn's, both with final readouts beforemid-2015."

Details of the DARWIN Phase 2B program

The Phase 2B program, named DARWIN (Drug Against Rheumatoid ArthritisWithSelective JAK1 INhibition) includes 2 dose finding studies, DARWIN 1 andDARWIN2, and an open label extension study, DARWIN 3. All patients will havereceivedmethotrexate (MTX) but no longer have an adequate therapeutic response tothisfirst-line therapy in RA. Patients will not have been exposed topriorbiological treatments.

DARWIN 1 will enroll 595 patients who will continue their stable therapyof MTXwhile receiving GLPG0634 or placebo, whereas in DARWIN 2, 280 patients willstopMTX and receive monotherapy of GLPG0634 or placebo. All patients whoreceiveplacebo or low dose GLPG0634 and do not show improvement after 12weeks oftreatment will be randomized to a higher dose of GLPG0634. Aftercompletion of24 weeks in either DARWIN 1 or 2, patients may continue open-labelGLPG0634 aspart of DARWIN 3, an extension study that will collect long-termsafety andefficacy data.

GLPG0634 doses in DARWIN 1 and 2 will be 50, 100 and 200 mg per day. InDARWIN1, these doses will be given as once-daily and twice-daily regimens (dailydosessplit in two), whereas only once-daily dosing will be evaluated in DARWIN2.The DARWIN program will recruit patients from Europe, the Americas,Australia,and New-Zealand.

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.

About Galapagos

Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is specialized innovel modes-of-action,with a large pipeline of four clinical, seven pre-clinical, and 30discoverysmall-molecule and antibody programs in 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 FFA2to 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.

First patients screened for Phase 2B studies with GLPG0634:

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Source: Galapagos NV via Thomson Reuters ONE



Galapagos NV
Piet Wigerinck
SVP Development
Tel: +32 477 62 7103

Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
Email Contact


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