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Galapagos begins midstage trial of investigational RA drug

Monday, May 14 2012 | Comments
Evidence Grade 0 What's This?
Galapagos NV initiated a second Phase IIa study of GLPG0634 in patients with rheumatoid arthritis (RA).

GLPG0634, a Janus kinase 1 (JAK1) inhibitor, will be evaluated in 90 patients with active RA who have not responded adequately to methotrexate. In particular, researchers will assess the efficacy, safety, tolerability and pharmacokinetics of once-daily dosing of 30 mg to 300 mg of GLPG0634. The trial participants will be divided into five groups of 18 and will receive GLPG0634 or placebo in addition to methotrexate for four weeks.

The main efficacy endpoint will be a 20 percent improvement from baseline in American College of Rheumatology criteria (ACR20). Secondary endpoints will include improvements in 28-joint Disease Activity Score and ACR50 and ACR70 rates. The study is expected to be completed by the end of this year.

In February, Galapagos entered into a global collaboration with Abbott that granted Abbott exclusive commercial rights to GLPG0634. The transaction was valued as high as $1.35 billion, including all up-front, licensing and milestone payments.

Under the agreement, Abbott made an up-front payment of $150 million. After the Phase II RA studies have been completed, and if they meet certain prespecified criteria, Abbott will license the GLPG0634 program for a one-time fee of $200 million and will assume sole responsibility for Phase III development activities and global manufacturing of the drug, which has the potential to treat multiple autoimmune diseases.

Galapagos could receive another $1 billion in other milestone payments, as well as royalties on sales of the product. The company retained rights to the compound in Belgium, the Netherlands and Luxembourg. Galapagos anticipates that GLPG0634 will reach the market in 2017.

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