Date: 2014-02-28
Type of information:
phase: 2
Announcement: update
Company: GSK (UK)
Product: GSK2586184 (formerly GLPG0778)
Action
mechanism: GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos\' osteoarthritis alliance with GSK. GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos' inflammation alliance with GSK. GSK in-licensed the molecule in February 2012, gaining worldwide rights to further development and commercialization. Galapagos is eligible, without further financial investment from Galapagos, to receive from GSK up to €34M in additional milestones, plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.
Disease: systemic lupus erythematosus
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On February 25, 2013, Galapagos has announced that GSK plan to initiate Phase 2 studies with GSK2586184 (formerly GLPG0778) in systemic lupus erythematosus. This 12 week, multi-center, dose-ranging, placebo-controlled Phase 2 study will investigate safety and efficacy of various doses of GSK2586184 in SLE patients. GSK2586184 is the second selective JAK1 molecule discovered by Galapagos to enter Phase 2 studies. GSK in-licensed the molecule in February 2012, gaining worldwide rights to further development and commercialization. Galapagos is eligible, without further financial investment from Galapagos, to receive from GSK €34M in additional milestones plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.* On February 28, 2014, Galapagos has announced that GSK has updated the development status for GSK2586184, involving three clinical studies in psoriasis, lupus, and ulcerative colitis.The Phase 2 study in systemic lupus erythematosis has been stopped at the planned first interim analysis by GSK due to a lack of effect. GSK notified Galapagos that the pre-defined stopping criteria were clearly met, triggering GSK to discontinue the lupus study with GSK2586184.
