Galapagos has begun the second Phase 2a clinical study of GLPG0634, a Janus kinase 1 (JAK1) inhibitor being developed to treat multiple autoimmune diseases, such as rheumatoid arthritis (RA).
The study will enrol 90 patients to assess the efficacy, safety, tolerability and pharmacokinetics of a once-daily dosing of 30mg to 300mg of GLPG0634 in treating rheumatoid arthritis.
The study’s primary objective will be an American College of Rheumatology 20% (ACR20) response rate, while the secondary endpoints include improvements in DAS28, ACR50 and ACR70 rates.
The previous four week proof-of-concept trial met the primary endpoint of improvement in ACR20 response rate and showed impressive results in secondary efficacy endpoints, including ACR50, ACR70, DAS28 and C-reactive protein.
The Phase 2a study of GLPG0634 is anticipated to be completed by the end of 2012.
Galapagos chief scientific officer Piet Wigerinck said the promising results from the proof-of-concept study clearly differentiate GLPG0634 from other JAK inhibitors in development in RA, both in terms of efficacy and safety.
"With the start of a broader Phase 2a 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.
"Meanwhile, the expansion of our development team is progressing on track, as we also prepare for the global Phase 2b study that should start next year."
Upon successful completion of the RA Phase 2b studies, Abbott will license the programme and will assume sole responsibility for Phase 3 clinical development and global manufacturing.
Galapagos, headquartered in Belgium, is a mid-size biotechnology company specialised in the discovery and development of small molecule and antibody therapies with novel modes-of-action.
Image: Rheumatoid arthritis is a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints. Photo courtesy of: James Heilman.