Mechelen, Belgium; 14 May 2012 - Galapagos NV (Euronext: GLPG) announced today that it has started its second Phase IIa clinical study with GLPG0634, a novel Janus kinase 1 (JAK1) inhibitor being developed to treat multiple autoimmune diseases, such as rheumatoid arthritis (RA). In this clinical study, the efficacy and safety of GLPG0634 will be evaluated for four weeks in RA patients, with completion planned by the end of 2012.
"The promising results from our Proof of Concept study clearly differentiate GLPG0634 from other JAK inhibitors in development in RA, both in terms of efficacy and safety. With the start of a broader Phase IIa study, we look forward to gathering dose-range finding data from 90 patients across multiple countries, adding to our understanding of the candidate drug's differentiation," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "Meanwhile, the expansion of our development team is progressing on track, as we also prepare for the global Phase IIb study that should start next year."
Details of the Phase IIa clinical study
The Phase IIa study for GLPG0634 will enroll 90 patients with active rheumatoid arthritis, showing an insufficient response to the standard-of-care treatment, methotrexate (MTX). The aim is to evaluate the efficacy, safety, tolerability and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in treating rheumatoid arthritis. Five groups of 18 patients with active disease will take the once-daily regimen of GLPG0634 or placebo for a period of four weeks, while all will continue to take their stable background therapy of MTX. The primary efficacy endpoint will be the ACR20 response rate, the standard primary endpoint for early response in RA clinical studies. Secondary endpoints include improvements in DAS28, ACR50 and ACR70 rates. Galapagos has received approvals to start the study in multiple sites across 4 different countries (Hungary, Moldova, Russia, and Ukraine), with patient recruitment currently underway. The study has been designed and is anticipated to deliver data by the end of 2012.
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 is a fully proprietary program. Upon successful completion of the RA Phase IIb studies, Abbott will license the program and will assume sole responsibility for Phase III clinical development and global manufacturing.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing GLPG0634, as well as one of the largest pipelines in biotech, with four programs in development and over 50 discovery programs. The Galapagos Group has about 800 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com
Piet Wigerinck, SVP Development
Tel: +32 477 62 7103
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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.
ACR20 (American College of Rheumatology 20%) response rate signifies a 20% or greater improvement in the number of swollen and tender joints as well as a 20% improvement in three out of five other disease-activity measures.