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Galapagos NV (Euronext: GLPG) will give an R&D Update today in New York City, highlighting the progress and plans for its portfolio of more than 40 research and development programs.
GLPG0634, an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, is about to enter Phase 2b studies. The program consists of 2 dose finding studies and an open label follow-up study and will be conducted in multiple study centers worldwide. Multiple dose levels will be tested, as well as once daily and twice daily regimens, during a period of 24 weeks. Details of this program will be discussed at the R&D Update.
In a separate release today, Galapagos announced achievement of excellent Phase 1 results with GLPG0974, the first inhibitor of FFA2 (formerly known as GPR43) to be evaluated clinically. Galapagos will initiate a Phase 2 Proof-of-Concept study with GLPG0974 in ulcerative colitis patients next month. The study will be completed by the end of this year.
In March 2011, Galapagos initiated a Phase 1b study with its integrin receptor antagonist in solid tumor patients to explore a maximum tolerated dose and a biomarker response. Galapagos will announce today that the enrollment was completed. The study confirmed the safety of GLPG0187 (no treatment related SAEs) and revealed early signs of clinical response in glioblastoma patients. Based on these results and following requests of the investigators, Galapagos has included additional patients in this study.
In 2010 Galapagos announced that it will pursue cystic fibrosis (CF) as the first orphan disease in which the company will discover, develop and launch its own medicines. This decision was based on the successful collaboration with the US CF Foundation. Galapagos is developing small molecule therapies to address the major CF mutation (delF508). Four separate programs are in drug discovery aimed at superior correctors and potentiators. Galapagos plans to nominate a first pre-clinical candidate potentiator later this year.
In 2007, Galapagos entered into a global collaboration with Lilly to develop novel mode of action therapies in osteoporosis. This alliance did not yield the expected results within an acceptable timeframe, and therefore Galapagos decided to end the alliance. The rights to the bone-building program have returned to Galapagos. During the collaboration with Lilly, Galapagos received a total of €11 M in payments.
In 2006 Galapagos and GSK initiated a drug discovery and development alliance to deliver disease modifying drugs for GSK's global R&D organization. GSK in-licensed GSK2586184 (formerly GLPG0778) and its corresponding back-up compound GLPG0555 in February 2012, gaining worldwide rights to further development and commercialization. GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos' alliance with GSK. GSK initiated a Phase 2 study with GSK2586184 in chronic plaque psoriasis and will initiate a Phase 2 study in systemic lupus erythematosus (SLE). GSK2586184 is the second selective JAK1 molecule discovered by Galapagos to enter Phase 2 studies. Galapagos is eligible, without further financial investment, to receive from GSK €34 M in additional milestones plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.
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