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news.Galapagos has commenced a proof-of-concept Phase II trial to investigate its novel Janus kinase (JAK) inhibitor GLPG0634 in rheumatoid arthritis (RA) patients.
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Galapagos expects to recruit around 36 subjects in the trial to investigate the safety, efficacy, tolerability and the pharmacokinetics of GLPG0634 in treating RA.
The primary efficacy endpoint will be the ACR20 response rate, the standard primary endpoint for RA clinical trials.
However, the secondary endpoints of the trial include improvements in DAS28, ACR50 and ACR70 rates and clinical score.
The preclinical results of the trial evaluating GLPG0634 in RA patients showed safety profile.
Galapagos Development SVP Piet Wigerinck said the current study with GLPG0634 is designed to show a fast onset of clinical response and will be completed by the end of this year.
"The pre-clinical and Phase I studies for this compound show a specific JAK1 inhibition profile, which could differentiate from other JAK compounds in development," Wigerinck said.