Mechelen, Belgium; 5 February 2013 – Galapagos NV (Euronext: GLPG) announced today that GlaxoSmithKline plan to initiate Phase 2 studies with GSK2586184 (formerly GLPG0778) in systemic lupus erythematosus (SLE) and chronic plaque psoriasis. GSK2586184 is the second selective JAK1 molecule discovered by Galapagos to enter Phase 2 studies.
GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos’ osteoarthritis 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 €34M in additional milestones plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.
“Inhibition of JAK1 is considered a promising new therapeutic route to treat inflammatory diseases. Galapagos is leading the field with two JAK1 inhibition molecules being tested in patients,” said Onno van de Stolpe, CEO of Galapagos. “With two of our JAK1 molecules in Phase 2, we hope that this will deliver a new class of medicines to patients with inflammatory diseases.”
GSK plans to initiate a 12 week, multi-center, dose-ranging, placebo-controlled Phase 2 study investigating safety and efficacy of various doses of GSK2586184 in SLE patients. Furthermore, GSK will also initiate a 12 week multi-center, dose-ranging, placebo-controlled Phase 2 study investigating the efficacy and safety of GSK2586184 in chronic plaque psoriasis.
About Systemic lupus erythematosus
Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by inflammation of many parts of the body. This inflammation is caused by the immune system that mistakenly attacks healthy cells, leading to tissue damage. The cause remains unknown, but SLE occurs more often in women, especially at childbearing age. SLE is more common in those of non-European descent, with prevalence ranges of 20 to 150 cases per 100.000 persons. Joint pain, muscle pain, fever, fatigue and malaise are the most common symptoms, and these can come and go unpredictably. Because these complaints are often observed with other diseases, diagnosis of SLE is difficult. Currently there is no cure for SLE, but the symptoms can be controlled by medicines, the most common of which are non-steroidal anti-inflammatory drugs (NSAID) and anti-malarial medicines. Those with more serious illness may require corticosteroids, immunosuppressants, but these have side-effects and are not always effective.
Psoriasis is an immune-mediated disease that affects the skin. It is caused by the immune system being mistakenly triggered, resulting in overproduction of new skin cells. The cause is not fully understood, but it is believed to have a genetic component and certain medications and infections are well-known risk factors. Psoriasis affects approximately 3% of people globally and it can occur at any age, although it most commonly appears for the first time between the ages of 15 and 25 years. There are five types of psoriasis with the most common form being plaque psoriasis, characterized by red patches covered by a silvery white scale appearing on the top first layer of the skin. Psoriasis can also cause inflammation of the joints, which is known as psoriatic arthritis, affecting between 10-30% of all people with psoriasis. Psoriasis is typically a lifelong condition and there is currently no cure, but various treatments can help to control the symptoms. Treating moderate to severe psoriasis usually involves a combination of treatment strategies: topical treatments, light therapy and/or systemic medications, including biologic drugs.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline of four clinical, six pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, about to enter Phase 2b studies. AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2b. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1b patient study in metastasis. GLPG0974 is the first inhibitor of GPR43 to be evaluated clinically for the treatment of IBD; this program will start a Proof of Concept Phase 2 study in Q2 2013.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has over 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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