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Galapagos is developing its novel mechanism of action, first-in-class candidate drug GLPG0259 for rheumatoid arthritis (RA). This is the first small molecule from Galapagos’ target discovery platform to enter the clinic. GLPG0259 targets protein kinase MAPKAPK5, which represents a new approach for the treatment of RA. 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 dose-finding efficacy trial in RA patients scheduled to begin in the third quarter of 2010. An interim readout of this trial is expected in Q2 2011 and the full Phase II results are planned for Q4 2011. GLPG0259 is 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 developing a second orally-available, small molecule for rheumatoid arthritis – GLPG0634. This novel candidate drug is selective against Janus kinase (JAK) 1 and 2 targets, a target class whose inhibition has already proven clinical efficacy in treating rheumatoid arthritis, and is fully owned by Galapagos. In August 2010, Galapagos initiated first-in-human studies for GLPG0634, with the aim to out-license the program at a later stage. For more information, contact Galapagos business development.
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