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Galapagos Initiates Second Phase I Clinical Trial for GLPG0259

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Galapagos NV has announced that it has initiated a second Phase I clinical trial for GLPG0259, a novel candidate drug being developed for rheumatoid arthritis (RA).

The new trial is based on the positive outcome of the first-in-human trial conducted earlier in 2009, which showed a good safety profile in healthy volunteers and pharmacokinetics (PK) supporting once daily oral dosing. The trial is aimed at assessing the combination of GLPG0259 with methotrexate (the current standard treatment for RA), and at extending the treatment duration.

Galapagos plans to conduct the multiple ascending dose study in 24 healthy volunteers using three 14-day dosing regimens. The results of the study will aid in the design of a Phase IIa study planned for 2010, where the efficacy of the novel candidate drug will be assessed in RA patients.

"We are pleased to progress our lead program based on our novel target discovery platform to this next step of clinical development," stated Onno van de Stolpe, Galapagos' CEO.

"This latest Phase I trial is designed to measure the longer term safety and tolerability profile of GLPG0259, while also assessing any interactions with the current standard treatment for RA. These results will provide information critical to the design of Phase II trials planned for next year, where we will evaluate the candidate drug's efficacy in treating RA patients."