Provide feedbackProvide feedback

Home :: Rheumatology :: Arthritis

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...

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.

Latest News

FDA committee supports approval of Pfizer's tofacitinib for RA Verusmed

Wednesday, May 09 2012 | Comments
Evidence Grade 0 What's This?

The Food and Drug Administration's Arthritis Drugs Advisory Committee voted 8-2 to recommend approval of Pfizer Inc.'s tofacitinib for the treatment of patients with moderately to severely active rheumatoid...

Tags: Arthritis


FDA reviewers express concerns about safety of Pfizer's RA drug candidate Verusmed

Monday, May 07 2012 | Comments
Evidence Grade 0 What's This?

Staff members from the Food and Drug Administration said Pfizer Inc.'s tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis (RA), is associated with "serious safety concerns," according to documents posted on the FDA's website ahead of an advisory panel meeting.

Tags: Arthritis


UCB's Cimzia meets primary endpoint in Phase III trial as treatment for axial spondyloarthritis Verusmed

Monday, April 16 2012 | Comments
Evidence Grade 0 What's This?

UCB Inc.'s Cimzia (certolizumab pegol) achieved the primary endpoint in a Phase III trial that evaluated the drug as a treatment for axial spondyloarthritis (AxSpA), a family of inflammatory rheumatic diseases that includes ankylosing spondylitis (AS).

The 24-week, double-blind trial included 325...

Tags: Arthritis


NicOx meets with FDA to discuss potential approval pathway for naproxcinod as treatment for knee OA Verusmed

Wednesday, April 04 2012 | Comments
Evidence Grade 0 What's This?

NicOx SA met with the Food and Drug Administration to discuss the proposed use of naproxcinod, an investigational nonsteroidal anti-inflammatory drug (NSAID), as a treatment for the signs and symptoms of osteoarthritis (OA) of the knee.

The firm noted that additional clinical data would be required before a New Drug Application (NDA) could be filed seeking approval to market naproxcinod 375 mg twice daily...

Tags: Arthritis




Rheumatology Conference Coverage
  1. No articles have been read
  1. No articles have been emailed
Videos