Galapagos NV announced that it has completed phase I clinical trials for GLPG0259, a novel mechanism-of-action candidate drug being developed for rheumatoid arthritis (RA). These results support the design of a phase II study planned to start later this year, where the efficacy of the novel candidate drug will be assessed in RA patients. Galapagos will present detailed results of GLPG0259 and other programs during an R&D Update scheduled for 19 March 2010.

The phase I studies for GLPG0259 have shown a good safety profile in healthy volunteers and confirm a once-daily oral dosing regimen. Furthermore, the studies have confirmed the feasibility of combining GLPG0259 with methotrexate (the current standard treatment for RA) in future trials. A similar safety and PK profile was observed for the capsule formulation of GLPG0259, which will be used in the phase II efficacy trial in RA patients scheduled to begin in the third quarter of 2010.

"This latest clinical study further demonstrated the safety and once-daily dosing of GLPG0259 in healthy volunteers and sets us on course to initiate an extended trial in rheumatoid arthritis patients," said Onno van de Stolpe, CEO of Galapagos. "We are very pleased with how this programme is progressing and excited that we are on track to start the assessment of the first Galapagos-based candidate drug in patients later this year."

GLPG0259 is a novel mechanism-of-action inhibitor of the protein kinase MAPKAPK5. It 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, 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 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 four clinical and over 40 small molecule discovery/pre-clinical programmes.