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GlaxoSmithKline's Phase IIa trial of GSK2586184 in chronic plaque psoriasis meets primary goal
17 April 2014 - 17 April 2014 - Belgian biotech group Galapagos NV (EBR:GLPG) said Thursday that its UK partner GlaxoSmithKline's (LON:GSK) Phase IIa trial of the selective JAK1 inhibitor, GSK2586184, in chronic plaque psoriasis had achieved the primary objective of >=75% improvement from baseline in Psoriasis Area Severity Index (PASI75) score at Week 12.

The multi-centre, randomised, double-blind, placebo-controlled, dose ranging trial (100mg bid, 200mg bid, 400mg bid) investigated the safety and efficacy of GSK2586184 versus placebo in 66 patients.

Proivisional findings demonstrated that significantly more patients who received GSK2586184 at the 400mg bid dose achieved the primary goal versus placebo. PASI75 for participants receiving placebo was in the range expected. 

The most frequent side effects in the trial, recorded with a frequency of over 20% on either placebo or pooled GSK2586184, included headache and nasopharyngitis. 

A final analysis of the trial findings will be filed for presentation at an upcoming scientific conference and/or a peer-reviewed publication.

GlaxoSmithKline plans to review the full results from all trials of the compound prior to determining next steps.

GSK2586184 is the second selective JAK1 inhibitor and candidate drug based on Galapagos' novel target approach to demonstrate efficacy in patients, commented the company's chief scientific officer Dr. Piet Wigerinck.

The agent has been discovered and developed under an inflammation collaboration between the companies. In February 2012, GlaxoSmithKline in-licensed GSK2586184, thus obtaining the global rights to further develop and market the compound. Galapagos is entitled to get up to EUR 34 million (USD 47.1m) in additional milestones from its partner, as well as up to double-digit royalties on global sales of all therapeutic indications of the drug.



 
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