Mechelen, Belgium; 28 September 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, 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 €60 million, with further potential milestones to Galapagos of €776 million and up to double-digit royalties on global sales.
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 €3.3 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
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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 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.