Clinical Trials

Date: 2014-11-06

Type of information: Results

phase: 2

Announcement: results

Company: GSK (UK)

Product: GSK2586184 (formerly GLPG0778)

Action mechanism:

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 up to €34M in additional milestones, plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.

Disease:

psoriasis

Therapeutic area: Autoimmune diseases- Dermatological diseases

Country: Germany, UK

Trial details:

Latest news:

* On November 6, 2014, Galapagos, a clinical stage biotech company focused on developing novel mode of action medicines, announces that GSK has disclosed the Phase 2 psoriasis study results with selective JAK1 inhibitor GSK2856184, licensed from Galapagos. The results show higher efficacy than those published for apremilast, a recently approved oral medicine for psoriasis and psoriatic arthritis. GSK completed a multi-center study with GSK2586184 in 56 subjects with moderate to severe plaque-type psoriasis. In a double-blind and placebo controlled study in 13 centers in Germany and the United Kingdom, patients received either 100, 200, or 400 mg GSK2586184 BID, or placebo BID. The treatment period was up to 12 weeks. Each patient had 7 visits: baseline, at the start of treatment, after weeks 2, 4, and 8, at the end of treatment after 12 weeks, and a follow up at week 16.

Efficacy results GSK2586184 versus apremilast:

 In addition, GSK reported open label study data in 8 psoriasis patients which confirmed the double-blinded data above. No clinically important changes in clinical chemistry, hematology and urinalysis values were observed, with the exception of 1 severe thrombocytopenia event (reported as a severe adverse event). In all GSK2586184 treatment groups, mean serum creatinine increased and remained elevated within the normal range (53-104.3 micro mol/L) throughout the study (highest mean increase of 12.5 micro mol/L). Together with the absence of change in cystatin C and eGFR it seems likely that the creatinine elevations reflect the interaction of GSK2586184 with renal tubular transporters sMATE1 and MATE2-K, rather than functional impairment. No changes in vital signs or ECGs were deemed clinically important.

" GSK2586184 met the primary endpoint in psoriasis, with a PASI75 score of 62% vs placebo score of 0% at the 400 mg dose, with consistent PASI50 and PASI90 scores, and with a favorable safety profile in this study. The reported efficacy scores are higher relative to those of apremilast, a recently approved oral therapy for psoriasis. Galapagos expects that oral therapies and antibody therapies may have different applications and opportunities in the field of psoriasis," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. GSK has informed Galapagos that GSK2586184 will not be developed by GSK for oral administration in psoriasis due to the overall risk/benefit profile, including a drug-drug statin interaction liability. GSK is evaluating other indications for development of GSK2586184.

* On April 17, 2014, Galapagos has announced 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."

* On February 28, 2014, Galapagos has announced that GSK has updated the development status for GSK2586184, involving three clinical studies in psoriasis, lupus, and ulcerative colitis. All dosing of patients in the Phase 2 study in psoriasis has completed. Topline efficacy and safety results from this study are expected in the first half of 2014. Galapagos is eligible to receive a milestone payment from GSK in the event that GSK achieves a successful Proof-of-Concept in patients treated with GSK2586184. The psoriasis study was designed to recruit 64 patients, with treatment up to 12 weeks.

* On February 2013, 25, Galapagos has announced that GSK plan to initiate Phase 2 studies with GSK2586184 (formerly GLPG0778) in chronic plaque psoriasis.  This 12 week multi-center, dose-ranging, placebo-controlled Phase 2 study will investigate the efficacy and safety of GSK2586184 in chronic plaque psoriasis.

GSK2586184 is the second selective JAK1 molecule discovered by Galapagos to enter Phase 2 studies. 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.

Is general: Yes