MECHELEN, BELGIUM--(Marketwire - November 08, 2012) -
· In a 4-week multicenter trial GLPG0634 repeats its
profile: it shows no serious adverse events and an absence of anemia and
to LDL and liver enzymes, which are typical side-effects reported for
· Clinical improvements seen in RA patients with once-daily
75-300mg, significant over placebo and the lower 30 mg dose
· Statistically significant improvements in ACR, HAQ-
DI, CRP, and
Mechelen, Belgium; 8 November 2012 - Galapagos NV (Euronext: GLPG)
today that a second Phase 2A clinical trial with GLPG0634 repeated the
safety of the drug, as well as the clinical benefit to RA patients
weeks. Clinical improvements were seen in RA patients with once-daily
of 75-300mg. GLPG0634 is the first selective JAK1 inhibitor in
RA. In February 2012, Galapagos and Abbott announced a global
GLPG0634 to treat autoimmune diseases.
In this four week, multi-center, Phase 2A trial in 91 RA patients,
administered in five study arms at a wide range of once-daily
placebo, 30, 75, 150 or 300 mg. Despite the fact that the study was not
for statistical significance, GLPG0634 did achieve statistically
improvement in CRP (C-reactive protein), DAS28, HAQ-DI and ACR response
the 300mg dose. Efficacy endpoints showed a rapid onset and sustained
until the end of the study. GLPG0634 was well-tolerated, with none
patients discontinuing the trial for safety reasons. No serious adverse
were reported. The safety profile of GLPG0634 was confirmed: an absence
typical findings reported with other JAK inhibitors such as anemia,
blood lipids (LDL) and effects on liver enzymes (ALT/AST). An
rather than a decrease in hemoglobin was observed in patients
"This larger, multi-center Phase 2A trial further supports the
positioning of GLPG0634: clinical efficacy combined with a differentiated
profile. This distinguishes GLPG0634 from other JAK inhibitors in
in RA. Dosing between 75 and 300 mg once daily demonstrated activity
several clinical parameters," said Dr Piet Wigerinck, Chief Scientific
of Galapagos. "These results enable us to move rapidly forward into
Phase 2B trials early next year."
Details of the Phase 2A clinical trial design
The Phase 2A trial for GLPG0634 enrolled 91 patients with active RA
arthritis), showing an insufficient response to the standard-of-care
methotrexate (MTX). The aim was to evaluate the efficacy, safety,
and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in
rheumatoid arthritis. Five groups of patients with active disease
once-daily regimen of GLPG0634 or placebo for a period of four weeks,
continued to take their stable background therapy of MTX. Efficacy
included the ACR20 and ACR50 response rates, the disease activity score
and the reduction in C-reactive protein (CRP), the primary blood
inflammation. Galapagos conducted the study in 19 test centers in
sites), Moldova (1), Russia (5), and Ukraine (9).
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor
selectivity for JAK1 developed by Galapagos. JAKs are critical
signaling mechanisms utilized by a number of cytokines and growth
including those that are elevated in rheumatoid arthritis patients.
inhibitors have shown long-term efficacy in rheumatoid arthritis studies
early onset of action. GLPG0634 differentiates from other JAK
development by specifically targeting JAK1, a strategy which could result
better efficacy and safety profile. GLPG0634 showed excellent clinical
and safety in Phase 2A studies in RA patients. GLPG0634 is a fully
program to Galapagos. Upon successful completion of the RA Phase 2B
Abbott will license the program and will assume sole responsibility for
clinical development, global manufacturing and registration.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology
specialized in the discovery and development of small molecule and
therapies with novel modes-of-action. The Company is progressing
well as one of the largest pipelines in biotech, with four
development and over 30 discovery programs. The Galapagos Group has about
employees and operates facilities in six countries, with global
Mechelen, Belgium. More info at: www.glpg.com
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Definitions of clinical parameters
ACR = American College of Rheumatology scores. These response rates
20%, 50% or 70% or greater improvement in the number of swollen and
joints as well as a similar percentage improvement in three out of five
DAS28 = Disease activity score based on measurement of 28 pre-defined
HAQ-DI = Health Assessment Questionnaire Disability Index, which
patient health based on a questionnaire completed by the patient.
CRP = C-reactive protein, a blood biomarker for inflammation.
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