Galapagos’ Phase I Study of RA Drug Shows Promise

Galapagos NV has successfully completed a Phase I trial of its drug candidate GLPG0259 for rheumatoid arthritis (RA). The drug showed good safety in healthy volunteers and an excellent pharmacokinetic profile, which supports once-daily oral dosing, according to the company. GLPG0259 is a new mechanism-of-action inhibitor of the protein kinase MAPKAPK5, which represents a new approach for the treatment of RA.

The double-blind, single-ascending and multiple dose study was conducted in 34 healthy volunteers. The compound was administered as many as five consecutive days and showed good safety, with no cardiovascular side effects. The desired PK profile obtained thus far supports once-daily oral dosing.

“We are encouraged by the positive outcome of the first human trial for a candidate drug derived from Galapagos’ target discovery platform,” said Onno van de Stolpe, chief executive officer of Galapagos. “We are on track to complete the Phase I trials for GLPG0259 by the end of 2009. Furthermore, preparations are underway to start a Phase IIa study in 2010, where we will assess the efficacy of this novel mechanism of action candidate drug in treating RA patients.”

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