Health Boards
Following on from Galapagos announces phase 2 study Galapagos have released the following information.
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“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.
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