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news.Galapagos has initiated Phase IIa clinical study designed to assess efficacy and safety of GLPG0634 in rheumatoid arthritis (RA) patients.
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GLPG0634 is a novel Janus kinase 1 (JAK1) inhibitor being developed to treat multiple autoimmune diseases.
Galapagos chief scientific officer Piet Wigerinck said the proof of concept study results differentiate GLPG0634 from other JAK inhibitors in development in RA, both in terms of efficacy and safety.
"With the start of a broader Phase IIa study, we look forward to gathering dose-range finding data from 90 patients across multiple countries, adding to our understanding of the candidate drug’s differentiation," Wigerinck added.
The study will enroll 90 RA patients showing an insufficient response to the standard-of-care treatment, methotrexate (MTX).
The ACR20 response rate, the standard primary endpoint for early response in RA clinical studies, will be the primary efficacy endpoint where as the improvements in DAS28, ACR50 and ACR70 rates will be secondary endpoints.