MECHELEN, BELGIUM--(Marketwire - September 28, 2010) - Galapagos NV (Euronext: GLPG) announced today that it has started a Phase II clinical study for the Company’s flagship program GLPG0259, a novel drug being developed for rheumatoid arthritis (RA). In this clinical trial, the safety and efficacy of this novel candidate drug will be tested in RA patients. Galapagos plans to announce interim results by the middle of next year and complete the trial by the end of 2011.
“This trial marks the first time a Galapagos novel target candidate drug is tested in patients,” said Onno van de Stolpe, CEO of Galapagos. “We are very proud of the high level of innovation that went into this program - from the cutting-edge science that led to this new target all the way to the innovative trial design, which will allow us to receive initial efficacy information for this candidate drug by the middle of next year.”
Details of the Phase II clinical trial
The clinical Proof-of-Concept Phase II trial for GLPG0259 will involve 180 RA patients with insufficient response to the standard-of-care treatment, methotrexate (MTX), with the aim to evaluate the efficacy and safety of GLPG0259 in treating rheumatoid arthritis. Patients with moderate to severe rheumatoid arthritis will be divided into four groups, all continuing to receive a stable background of MTX, with three groups receiving a different once-daily dose of GLPG0259 and the fourth group receiving a placebo, for a period of 12 weeks. The primary endpoint will be the ACR20 response rate[1], the standard primary endpoint for RA clinical trials. Galapagos has received regulatory approvals to start the pan-European trial, with patient recruitment beginning next month. The trial has been designed to obtain initial efficacy data using the highest dose for the first 30 patients (20 receiving GLPG0259, 10 receiving placebo) in the first half of 2011. Based on this initial readout, Galapagos plans to complete the dose-finding component of the trial by the end of 2011.
About MAPKAPK5 and candidate drug GLPG0259
Protein target MAPKAPK5 is a new starting point for the treatment of rheumatoid arthritis (RA). Galapagos discovered and validated the key role of this target in the RA disease process, using its proprietary target discovery technology. MAPKAPK5 had not been previously associated with RA; however, Galapagos has shown that it plays a key role in inflammation and in the breakdown of collagen in human cartilage. The candidate drug GLPG0259 inhibits MAPKAPK5 in human cells, and demonstrates excellent bone protection and reduced inflammation in a standard RA animal model.
Phase I clinical studies for GLPG0259 in healthy volunteers demonstrated good safety and once-daily oral dosing for the capsule formulation used in this Phase II trial. The feasibility of combining GLPG0259 with MTX was also confirmed in the Phase I trial.
GLPG0259 is a compound in Galapagos’ internal RA program, which is part of an option agreement with Janssen Pharmaceutica. Upon the completion of a dose-finding Phase II clinical trial for GLPG0259 scheduled to be completed by year end 2011, Janssen has the exclusive option to license the program for EUR60 million, with further potential milestones to Galapagos of EUR776 million and up to double-digit royalties on global sales.
About Galapagos
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 six clinical and over 50 small molecule discovery/pre-clinical programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Merck & Co., Roche and Servier, Galapagos is eligible to receive up to EUR3.3 billion in downstream milestones, plus royalties. Following the acquisition of the Zagreb research center, the Galapagos Group now has over 800 employees and operates facilities in seven countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com
CONTACT Galapagos NV Onno van de Stolpe, CEO Tel: +31 6 2909 8028 Elizabeth Goodwin Director Investor Relations Tel: +31 6 2291 6240 ir@glpg.com 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.
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[1] 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.
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Source: Galapagos NV via Thomson Reuters ONE
