Wednesday, November 7, 2012

Galapagos - GLPG0634 a potential competitor to Pfizer's Tofacitinib demonstrates robust Phase 2 data with a differentiated safety profile

The Phase2 A data, demonstrates that GLPG0634 has robust efficacy and a differentiated safety profilePfizer's Tofacitinib which has received USFDA approval is a  JAK inhibitor (selective for JAK3) unlike GLPG0634 which is selective for JAK1. Unlike Tofacitinib GLPG0634 has so far not shown safety issues related to LDL increase and liver enzyme elevation.


GLPG0634 Phase 2 A trial Design

The Phase 2A trial for GLPG0634 enrolled 91 patients with active RA (rheumatoid arthritis), showing an insufficient response to the standard-of-care treatment, methotrexate (MTX).  The aim was to evaluate the efficacy, safety, tolerability and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in treating rheumatoid arthritis.  
Five groups of patients with active disease took the once-daily regimen of GLPG0634 or placebo for a period of four weeks, while all continued to take their stable background therapy of MTX.  Efficacy endpoints included the ACR20 and ACR50 response rates, the disease activity score DAS28, and the reduction in C-reactive protein (CRP), the primary blood marker of inflammation.  Galapagos conducted the study in 19 test centers in Hungary (4 sites), Moldova (1), Russia (5), and Ukraine (9). 

GLPG0634 - Efficacy  Data

In this four week, multi-center, Phase 2A trial in 91 RA patients showing an insufficient response to methotrexate, GLPG0634 was administered in five study arms at a wide range of once-daily dosages of placebo, 30, 75, 150 or 300 mg.  Despite the fact that the study was not powered for statistical significance, GLPG0634 did achieve statistically significant improvement in CRP (C-reactive protein), DAS28, HAQ-DI and ACR response rates at the 300mg dose.

GLPG0634 - Safety Data

The safety profile of GLPG0634 was confirmed: an absence of the typical findings reported with other JAK inhibitors such as anemia, increases in blood lipids (LDL) and effects on liver enzymes (ALT/AST).  An improvement rather than a decrease in hemoglobin was observed in patients receiving GLPG0634.   There were so serious safety issues

About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos

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