Mechelen, Belgium; 6 November 2014: Galapagos NV (Euronext: GLPG), a clinical stage biotech company focused on developing novel mode of action medicines, announces that GSK has disclosed on its website 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:
| Proportion of PASI 50, 75 and 90 responders at Week 12 | ||||||
| GSK2586184 BID | apremilast[1] BID at Week 16 | |||||
| PASI | Placebo BID | 100 mg | 200 mg | 400 mg | 30 mg | |
| PASI 50 | 0 % (0/11) | 29% (4/14) | 36% (4/11) | 69% (9/13) | ||
| PASI 75 | 0 % (0/11) | 14% (2/14) | 36% (4/11) | 62% (8/13) | 33% vs 5% placebo | |
| PASI 90 | 0 % (0/11) | 0% (0/14) | 36% (4/11) | 38% (5/13) | ||
In addition, GSK reported open label study data in 8 psoriasis patients which confirmed the double-blinded data above.
GSK reported the following safety results:
"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 is the second compound discovered by Galapagos to show good efficacy and safety, after selective JAK1 inhibitor GLPG0634 in rheumatoid arthritis. 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.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a pipeline comprising three Phase 2 studies, two Phase 1 studies, five pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics and metabolic disease. In the field of inflammation, AbbVie and Galapagos signed an agreement for the development and commercialization of GLPG0634. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn's disease. Galapagos has another selective JAK1 inhibitor, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). AbbVie and Galapagos signed an agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is expected to start Phase 1 in 2014. Galapagos also expects to nominate a pre-clinical candidate corrector before year end 2014. The Galapagos Group, including fee-for-service subsidiary Fidelta, has around 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com
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[1]Source: Celgene website, press release dated March 2, 2013 containing Phase 3 study results.