Galapagos NV 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 positive outcomes from the first-in-human trial conducted earlier in 2009, which showed a good safety profile supporting once-daily oral dosing.
The new trial is aimed at assessing the combination of GLPG0259 with methotrexate, the 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.
Galapagos CEO Onno van de Stolpe said that 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 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," Stolpe said.