Galapagos reports high participation rate in long term extension study with GLPG0634 in RA patients

Mechelen, Belgium; 18 September 2014 – Galapagos NV (Euronext: GLPG) announced today that more than 100 patients have completed the six month Darwin 1 and 2 studies with GLPG0634 in rheumatoid arthritis and entered Darwin 3, the long term extension study.  With the support of their treating physicians, over 90% of the patients who participated in Darwin 1 and Darwin 2 have chosen to participate in Darwin 3, in which all patients will receive long term treatment with Galapagos’ highly selective JAK1 inhibitor.

The Darwin Phase 2B program initiated last year with GLPG0634 includes two dose finding studies (595 patients: Darwin 1/methotrexate add-on and 280 patients: Darwin 2/monotherapy) and an open label extension study (Darwin 3).  Over 1,000 patients have been screened to date, and overall recruitment is making good progress.

“We are particularly pleased to know that over 90% of participating patients are interested in receiving long term treatment with GLPG0634 and that their rheumatologists support that choice.  This gives confidence in GLPG0634 therapy,” said Dr Piet Wigerinck, CSO of Galapagos.  “We remain on track to complete recruitment on time and expect topline 12 week results in Q1 2015.”

Details of the Darwin Phase 2B program
The Phase 2B program, named Darwin (Drug Against Rheumatoid Arthritis With Selective JAK1 INhibition) includes 2 dose finding studies, Darwin 1 and Darwin 2, and an open label extension study, Darwin 3.  All patients received methotrexate (MTX) but no longer have an adequate therapeutic response to this first-line therapy in RA. 

Darwin 1 is enrolling 595 patients who continue their stable therapy of MTX while receiving GLPG0634 or placebo, whereas in Darwin 2, 280 patients stop MTX and receive monotherapy of GLPG0634 or placebo.  All patients who receive placebo or low dose GLPG0634 and do not show improvement after 12 weeks of treatment are randomized to a higher dose of GLPG0634.  After completion of 24 weeks in either Darwin 1 or 2, patients may continue open-label, treatment with GLPG0634 as part of Darwin 3, an extension study that will collect long-term safety and efficacy data.

GLPG0634 doses in Darwin 1 and 2 range from 50 to 200 mg per day.  In Darwin 1, these doses are given as once-daily and twice-daily regimens (daily doses split in two), whereas only once-daily dosing are evaluated in Darwin 2. The Darwin program is recruiting patients from Europe, the Americas, Australia, and New-Zealand.

About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising three Phase 2 studies, two Phase 1 studies, five pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.  In the field of inflammation, AbbVie and Galapagos signed an agreement for the development and commercialization of GLPG0634.  GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn’s disease.  Galapagos has another selective JAK1 inhibitor, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012).  GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program has completed a Proof-of-Concept Phase 2 study.  GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1.  GLPG1690 is a first-in-class compound that targets pulmonary diseases and is currently in a Phase 1 study.  AbbVie and Galapagos signed an agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene.  Potentiator GLPG1837 is at the pre-clinical candidate stage.  The Galapagos Group, including fee-for-service subsidiary Fidelta, has around 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia.  Further information at:


Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240

Galapagos forward-looking statements
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.