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Galapagos GLPG0634 Phase II study meets primary endpoint

Galapagos' JAK1 inhibitor, GLPG0634 met its primary endpoint of improvement in the signs and symptoms of rheumatoid arthritis (RA), as evident from phase II study data.

GLPG0634 is a selective inhibitor of JAK1 (Janus kinase 1) used for treating inflammatory conditions like rheumatoid arthritis (RA).

In the four week, proof-of-concept trial involving 36 RA patients, GLPG0634 was administered in two dosage arms of 200 mg; one group taking a once-daily dose (QD), and the other taking twice-daily doses of 100 mg (BID).

The data demonstrated that the drug candidate was well-tolerated, met the primary endpoint and yielded good results in secondary efficacy endpoints.

Anemia or increases in lipids (LDL or cholesterol) was not observed.

The company intends to begin an extended dose-range finding study for GLPG0634 in the first half of 2012 to further determine the optimal doses in longer term studies in patients.