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Psoriasis Drug Meets Primary Endpoint in Phase II Study

GSK2586184 improves Psoriasis Area Severity Index

Study JAK116679 was a phase IIa, randomized, double-blind, placebo-controlled, dose-ranging trial that evaluated the safety and efficacy of GSK2586184 (formerly GLPG0778, GlaxoSmithKline/Galapagos NV) at a dosage of 100 mg twice daily (BID), 200 mg BID, or 400 mg BID compared with placebo in 66 patients with chronic plaque psoriasis.

Preliminary results have shown that a significantly higher proportion of patients treated with GSK2586184 at the 400-mg BID dosage met the study’s primary endpoint compared with those given placebo. The primary endpoint was defined as achieving ≥ 75% improvement from baseline in the Psoriasis Area Severity Index (PASI 75) score at week 12. PASI 75 scores for patients given placebo were in the expected range.

During the treatment period, the most common adverse events occurring with a frequency of more than 20% for either pooled GSK2586184 or placebo were headache (27% vs. 36%, respectively) and nasopharyngitis (29% vs. 21%).

GSK2586184 is a selective JAK1 inhibitor that was discovered and developed during an inflammation alliance between GlaxoSmithKline and Galapagos NV. GSK licensed the molecule in February 2012, gaining worldwide rights to further development and commercialization.

In the field of inflammation, Galapagos has also signed a worldwide license agreement with AbbVie whereby AbbVie will be responsible for further development and commercialization of GLPG0634 after phase IIb. GLPG0634 is an orally available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis (RA) and potentially other inflammatory diseases. The compound is currently in phase IIb studies in RA and in phase II in Crohn’s disease.

GLPG0974 is the first inhibitor of the free fatty acid 2 (FFA2) receptor to be evaluated clinically for the treatment of irritable bowel disease (IBD); this compound is currently in a proof-of-concept phase II study.

AbbVie and Galapagos have signed an agreement whereby they are working collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene — the G551D and F508del mutations — in cystic fibrosis. Potentiator GLPG1837 is at the preclinical candidate stage.

Source: Galapagos NV; April 17, 2014.

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