Mechelen, Belgium; 17 April 2014 – Galapagos NV (Euronext: GLPG) announced today that GSK provided Galapagos with the following information:
“Study JAK116679 was a phase 2a multi-centre, randomised, double-blind, placebo-controlled, dose ranging study (100mg bid, 200mg bid, 400mg bid) that evaluated the safety and efficacy of GSK2586184 compared with placebo in 66 patients with chronic plaque psoriasis. Preliminary results showed that a significantly higher proportion of patients treated with GSK2586184 at the 400mg bid dose met the primary endpoint compared to placebo. The primary endpoint was defined as achieving >=75% improvement from baseline in Psoriasis Area Severity Index (PASI75) score at Week 12. PASI75 for patients randomised to placebo was in the range expected.
During the treatment period the most common adverse events occurring with a frequency of more than 20% on either placebo or pooled GSK2586184 were headache (36% placebo, 27% GSK2586184) and nasopharyngitis (21% placebo, 29% GSK2586184). A final analysis of the data from study JAK116679 will be submitted for presentation at an upcoming scientific congress and/or a peer-reviewed publication. GSK remains responsible for the study and intends to review the complete data from all GSK2586184 studies before determining next steps.“
“We at Galapagos are pleased to hear that GSK2586184 met the primary endpoint in GSK’s psoriasis study. This is the second selective JAK1 inhibitor and candidate drug based on Galapagos’ novel target approach to show efficacy in patients. The next patient readout from our pipeline is expected in June 2014: our Phase 2 Proof of Concept study with GLPG0974, a fully proprietary and novel mode of action in ulcerative colitis,” said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.
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.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising five Phase 2 studies (two led by GSK), one Phase 1 study, six pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. In the field of inflammation, AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization of GLPG0634 after Phase 2B. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn’s disease. Selective JAK1 inhibitor GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012) met the primary endpoint in a Phase 2 study in psoriasis. An exploratory Phase 1/2 study in ulcerative colitis is currently on hold. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1. AbbVie and Galapagos signed an agreement in CF whereby they work collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene, the G551D and F508del mutation. Potentiator GLPG1837 is at the pre-clinical candidate stage. Galapagos has 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com
For media and investor inquiries:
Elizabeth Goodwin, Head of Corporate Communications & Investor Relations
Tel: +31 6 2291 6240
This release may contain forward-looking statements, including, without limitation, statements containing the words “believes,” “anticipates,” “expects,” “intends,” “plans,” “seeks,” “estimates,” “may,” “will,” “could,” “stands to,” and “continues,” as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.