Galapagos presents GLPG0634 at EULAR poster session
(Thomson Reuters ONE) -
Posters now available online at www.glpg.com
Q&A session with Galapagos CSO today at 15.00 CET/9 AM EDT/6 AM PT, call numbers
for the teleconference call: US +1-480-629-9645, Toll-free +1-877-941-60;
Belgium +32-2290-1608, Toll-free 0800-50747; Netherlands +31 20 794 8504, Toll-
free 0800-265-8528
Mechelen, Belgium; 13 June 2013 - Galapagos NV (Euronext: GLPG) is presenting
three posters on its selective JAK1 inhibitor GLPG0634 at the European League
Against Rheumatism (EULAR) Annual Congress taking place this week in Madrid,
Spain. The posters are available online at www.glpg.com.
Chief Scientific Officer Dr Piet Wigerinck will answer questions about the
posters in a teleconference call at 15.00 CET/9 am EDT/6 am PT, call numbers US
+1-480-629-9645, Toll-free +1-877-941-60; Belgium +32-2290-1608, Toll-free
0800-50747; Netherlands +31 20 794 8504, Toll-free 0800-265-8528. A recording
of the teleconference call will be archived on Galapagos' website.
Following is an overview of the posters, with key conclusions:
Safety and efficacy of GLPG0634, a selective JAK1 inhibitor, in patients with
rheumatoid arthritis: results of a 4-week Phase IIA dose ranging, multi-center
trial
Selective inhibition of JAK1 by once-daily dosing of GLPG0634 from 75 - 300 mg
was well tolerated and efficacious in this 4-week study. A favourable safety
profile was observed, with an absence of the typical findings reported for other
JAK inhibitors. GLPG0634 caused no anemia, no overall change to LDL or ALT, and
no neutropenia. Regarding efficacy, a dose trend for improvement in RA disease
parameters was found: 30 mg QD was sub-optimal, while doses of 75, 150 and 300
mg showed promising efficacy, with similar response rates in CRP, TJC, SJC and
DAS28.
An imbalance in baseline characteristics of two patient groups may have
influenced the study outcome:
· the placebo group showed a relatively high response rate correlating with
a short history of RA
· the 150 mg group was most severely diseased. The 150 mg group showed a
robust response in CRP, TJC, and SJC. However, the 4-week duration of the trial
was too short to reach the full potential on patient-reported scores (pain
assessment, global assessment, HAQ-DI).
The encouraging short term efficacy and favourable safety profile in this study
supports the potential of selective inhibition of JAK1 as a future RA treatment
option, and confirms data from a previous Proof of Concept study at a 200 mg
daily dose.
Once-daily dosing of GLPG0634, a selective JAK1 inhibitor, is supported by its
active metabolite
An active and JAK1-selective metabolite supports the activity of GLPG0634. The
lower potency of the metabolite is compensated by its high exposure in humans.
The long half-life of the metabolite and the resulting high plasma levels when
parent GLPG0634 is at trough, provides a lasting effect. Because of the 7-hour
half-life of GLPG0634, both BID and QD regimens were studied. However, the
metabolite contribution to JAK1 inhibition now provides a potential explanation
for the sustained efficacy results observed with once daily dosing of GLPG0634,
adding to convenience for patients.
Biological effects of the JAK1 selective inhibitor GLPG0634 on inflammation
markers in arthritic mice
Oral administration of the selective JAK1 inhibitor GLPG0634 in arthritic mice
demonstrates a selective engagement of the JAK1 target by GLPG0634 in vivo.
Progression of established arthritis in the CIA model is blocked by selective
inhibition of JAK1. GLPG0634 administration inhibits inflammation and confers
structural protection at the level of bone and cartilage in a therapeutic CIA
model. A single administration of GLPG0634 is sufficient to block CIA-induced
inflammatory signalling.
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with
selectivity for JAK1 developed by Galapagos. JAKs are critical components of
signalling mechanisms utilized by a number of cytokines and growth factors,
including those that are elevated in rheumatoid arthritis patients. JAK
inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an
early onset of action. GLPG0634 differentiates from other JAK inhibitors in
development by specifically targeting JAK1, a strategy which could result in a
better efficacy and safety profile. GLPG0634 is a fully proprietary program.
Upon successful completion of the Phase 2b studies in RA, AbbVie will license
the program and will assume sole responsibility for Phase 3 clinical development
and global manufacturing. Furthermore, AbbVie and Galapagos recently announced
the initiation of a Phase 2 study with GLPG0634 in Crohn's Disease.
About EULAR
The annual EULAR congresses are a major event in the calendar of world
rheumatology. The aim is to provide a forum of the highest standard for
scientific (both clinical and basic), educational and social exchange between
professionals involved in rheumatology, liaising with patient organisations, in
order to achieve progress in the clinical care of patients with rheumatic
diseases. More info at: www.eular.org
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a large pipeline of four clinical, seven pre-clinical, and 30 discovery
small-molecule and antibody programs in cystic fibrosis, inflammation,
antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment
of rheumatoid arthritis and potentially other inflammatory diseases, currently
in Phase 2b studies in RA and about to enter Phase 2 studies in Crohn's
disease. AbbVie and Galapagos signed a worldwide license agreement whereby
AbbVie will be responsible for further development and commercialization after
Phase 2b. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus
and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in
2012). GLPG0187 is a novel integrin receptor antagonist currently in a Phase
1b patient study in metastasis. GLPG0974 is the first inhibitor of GPR43 to be
evaluated clinically for the treatment of IBD; this program is currently in a
Proof of Concept Phase 2 study.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and
Fidelta, has 800 employees and operates facilities in five countries, with
global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
CONTACT
Galapagos NV
Piet Wigerinck, CSO
Tel: +32 477 62 7103
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)glpg.com
This release may contain forward-looking statements, including, without
limitation, statements containing the words "believes," "anticipates,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will," "could,"
"stands to," and "continues," as well as similar expressions. Such forward-
looking statements may involve known and unknown risks, uncertainties and other
factors which might cause the actual results, financial condition, performance
or achievements of Galapagos, or industry results, to be materially different
from any historic or future results, financial conditions, performance or
achievements expressed or implied by such forward-looking statements. Given
these uncertainties, the reader is advised not to place any undue reliance on
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of the date of publication of this document. Galapagos expressly disclaims any
obligation to update any such forward-looking statements in this document to
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events, conditions or circumstances on which any such statement is based, unless
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Galapagos presents GLPG0634 at EULAR poster session:
http://hugin.info/133350/R/1709038/566354.pdf
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Datum: 13.06.2013 - 09:19 Uhr
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News-ID 269296
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