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news.Galapagos has completed Phase I clinical trials for GLPG0259, a novel mechanismof-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.
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Galapagos said that 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 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.
Onno van de Stolpe, CEO of Galapagos, said: “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. We are very pleased with how this program 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.”