Galapagos discontinues Phase II trial for GLPG0259, focuses resources on other rheumatoid arthritis programs

19-Apr-2011 - Belgium

Galapagos NV announced that it will discontinue its Phase II clinical trial for GLPG0259 in rheumatoid arthritis. This decision is based on the outcome of a planned interim analysis which did not support the continuation of GLPG0259's development for rheumatoid arthritis.

An Interim Review Committee of key opinion leaders in the field of rheumatology analyzed unblinded safety and efficacy data from the first 30 patients. Twenty patients received GLPG0259 and ten patients received placebo for a twelve week period. No serious adverse events or safety signals were reported. However, the committee recommended that study be discontinued due to limited efficacy potential of the compound in the Phase II trial. Galapagos intends to complete a full analysis of the data package prior to making a decision on the next steps for GLPG0259, including the position of the compound in other indications.

Galapagos will focus resources on its clinical programs in rheumatoid arthritis, cancer metastasis and cachexia, and on accelerating development of other candidate drugs in its broad portfolio. The Company has a large discovery pipeline in rheumatoid arthritis, including four novel mode-of-action molecules currently in late stage discovery under its rheumatoid arthritis research programs with Janssen Pharmaceutica NV.

"The innovative trial design used in this Phase II trial enabled quick determination regarding GLPG0259's potential efficacy in RA. We will now focus on accelerating the development of our other programs and continue to leverage our unique discovery platform to bring novel modes-of-action to the clinic," said Onno van de Stolpe, CEO of Galapagos. "Galapagos remains on-track to deliver the remainder of its operational objectives in 2011 as well as meet full year financial guidance of at least €150 million in revenues, profitability and positive cash flow in 2011."

https://www.bionity.com/en/news/132023/galapagos-discontinues-phase-ii-trial-for-glpg0259-focuses-resources-on-other-rheumatoid-arthritis-programs.html