GLPG0634 preclinical/Phase I poster presentation tomorrow at ACR 2011
Mechelen, Belgium; 7 November 2011- Galapagos NV (Euronext: GLPG) announced today that it will disclose topline results from the Phase II Proof-of-Concept trial for GLPG0634, a selective inhibitor of JAK1 (Janus kinase1), in rheumatoid arthritis patients on 22 November 2011. Financial analysts, investors, and journalists are invited to attend a webcast press conference to be held at the Galapagos operations in Leiden, Netherlands, starting at 15.00 CET/9:00 AM EST/6:00 AM PST.
Preclinical and Phase I clinical results for GLPG0634 will be presented tomorrow at the American College of Rheumatology Annual Meeting (ACR) taking place 5-9 November 2011 at McCormick Place in Chicago:
GLPG0634 Shows Selective Inhibition of JAK1 and Maintained JAK-STAT Suppression in Healthy Volunteers (8-Nov, 9:00 – 11:00 AM, Poster presentation #2210)
The presented data demonstrate that GLPG0634 shows selective JAK1 inhibition, good safety and maintained JAK1-related biomarker response for up to 10-days after dosing in healthy volunteers. Biomarker data also show that JAK1 is inhibited throughout the day for once-daily dosing of GLPG0634 in healthy volunteers.
Details of the Phase II clinical trial
The clinical Proof-of-Concept Phase II trial for GLPG0634 involved 36 patients with active rheumatoid arthritis, showing an insufficient response to the standard-of-care treatment, methotrexate (MTX). The aim is to evaluate the efficacy and safety of GLPG0634 in treating rheumatoid arthritis. Three groups of 12 patients with moderate to severe disease received either a once- or twice-daily dose regimen of GLPG0634 or placebo, for a period of four weeks, while all continued to take a stable background therapy of MTX. The primary efficacy endpoint will be the ACR20 response rate, the standard primary endpoint for RA clinical trials. Secondary endpoints include improvements in DAS28, ACR50 and ACR70 rates. The safety and tolerability, and the pharmacokinetics of GLPG0634 in rheumatoid arthritis patients will also be evaluated.
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 trials with an early onset of action. Galapagos aims to differentiate GLPG0634 from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a cleaner safety profile.
GLPG0634 has demonstrated excellent activity in in vitro biochemical studies and in vivo models of rheumatoid arthritis, and has successfully completed pre-clinical development and Phase I studies in healthy volunteers.
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 one of the largest pipelines in biotech, with seven programs in development and over 50 discovery programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is eligible to receive up to €2.8 billion in downstream milestones, plus royalties. 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
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
To attend the 22 November event in person at Galapagos’ facilities in Leiden, please register through firstname.lastname@example.org.
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.