比利时生物技术公司Galapagos 4月17日宣布，与合作伙伴葛兰素史克（GSK）合作开发的皮肤病药物GSK2586184的一项IIa期研究JAK116679已成功结束，初步结果表明，该项研究达到了主要终点。
JAK116679是一项多中心、随机、双盲、安慰剂对照、剂量范围（100mg bid，200mg bid，400mg bid，bid意为每天2次）IIa期研究，在66例慢性斑块型银屑病（chronic plaque psoriasis）患者中开展，评估了GSK2586184相对于安慰剂的疗效和安全性。初步结果表明，与安慰剂相比，400mg bid剂量组有显著更高比例的患者在12周时银屑病面积严重程度指数从基线水平取得≥75%的改善（PASI75），达到了研究的主要终点。而安慰剂组，PASI75在预期范围内。
该项研究中，最常见的不良反应为头痛、鼻咽炎。研究的最终分析数据将提交至即将召开的科学会议。GSK仍将负责该项研究，并有意在审查有关GSK2586184所有研究的数据之后，再决定下一步的行动。
GSK2586184是一种选择性JAK1抑制剂，由Galapago与GSK达成的炎症联盟发现和开发。GSK于2012年2月授权获得该药物进一步开发和商业化的全球性权利。
：GSK2586184 met primary endpoint in Phase 2a psoriasis study
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 eva1uated 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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