Galapagos NV has announced an expansion of the Phase 2b program with GLPG0634 in rheumatoid arthritis (RA). Galapagos will increase the number of patients in the Phase 2b program to 875.
AbbVie will provide an additional payment of $20 million to Galapagos prior to the start of the Phase 2b program in RA to fund the program's expansion to 875 patients.
GLPG0634 is the first selective JAK1 inhibitor in development for autoimmune diseases. In February 2012, Galapagos and AbbVie announced a global collaboration for GLPG0634 to treat autoimmune diseases.
In November 2011 Galapagos announced promising efficacy and safety in a 4 week Proof of Concept study in RA.
The results of the 4-week Phase 2a clinical study repeated the clinical benefit and safety of the drug seen in the Proof of Concept study.
Galapagos will initiate a 24-week global Phase 2b program in RA in Q2 2013, with trial design finalized by both Galapagos and AbbVie.
The total number of patients to be included in the Phase 2b program will be expanded to 875, which will facilitate a final dose and regimen selection for Phase 3 clinical studies. Galapagos expects to report topline data from the Phase 2b program in Q4 2014.
"We welcome AbbVie's support for expanding the GLPG0634 Phase 2b program in RA. This will optimize the program to explore the once- and twice-daily dosing profile of GLPG0634. The program is on track, with the start of the Phase 2b trials in this quarter. We benefit from the growing experience with JAK inhibitors in clinical development and on the market, which has helped us to design data-rich studies, preparing an efficient continuation into pivotal studies in Phase 3," said Onno van de Stolpe, CEO of Galapagos.