Galapagos cystic fibrosis program progresses towards therapy for largest patient group
17 Junho 2014 - 2:39AM
- Review of CF and other highlighted programs in today's
R&D update
- GLPG0634 DARWIN 1 study to deliver 12 week topline data
in Q1 2015
- GLPG0974 shows biomarker effect & good safety in
ulcerative colitis patients, but lacks clinical improvement in 4
week Proof-of-Concept study
- GLPG1492 mode of action scalable to ESKAPE and other
pathogens
- Multiple Phase 2 readouts with novel modes-of-action in
coming two years
Live webcast presentation today at 8:00 am
ET/2:00 pm CET on www.glpg.com , call number +32 2 404
0660, confirmation code 2952966
MECHELEN, Belgium, June 17, 2014 (GLOBE
NEWSWIRE) -- Galapagos NV (Euronext: GLPG) will give an
R&D Update today in New York City, highlighting the company
strategy, progress and plans for its portfolio of more than 35
R&D programs.
R&D strategy Galapagos
selects diseases with large, unmet medical need and discovers novel
mode-of-action medicines to address these diseases. The
Company's R&D focus on inflammation, orphan, anti-infectives,
and fibrosis has yielded a substantial pipeline with multiple Phase
2 readouts the coming two years. Galapagos seeks to partner
programs at an optimal stage, with the ambition to ring fence
certain proprietary programs.
GLPG0634 Selective JAK1
inhibitor GLPG0634 has shown a best-in-class profile in two
rheumatoid arthritis Phase 2 studies. GLPG0634 is currently
in a global Phase 2b program (DARWIN) in 875 rheumatoid arthritis
patients and a Phase 2 study in 180 patients with Crohn's
disease. Due to longer than anticipated approval rounds with
national regulators, topline 12 week results for DARWIN 1 (595
patients, methotrexate add-on) are expected in Q1 2015, DARWIN 2
(280 patients, monotherapy) topline 12 week results are expected in
Q2 2015, with complete 24 week data package expected in Q3
2015. Topline data from the Phase 2 study in Crohn's disease
remains on track for disclosure in Q2 2015. AbbVie will base
its licensing decision on the complete 24 week DARWIN data package
from GLPG0634.
GLPG0974 topline results
GLPG0974 is the first selective antagonist of FFA2 to be tested in
the clinic. GLPG0974 showed good results in Phase 1 studies
and recently completed a 4-week Phase 2 proof-of-concept study in
45 ulcerative colitis (UC) patients in 16 centers in 4 European
countries. Patients received 200 mg of GLPG0974 twice-daily
for 4 weeks. Patients on treatment tolerated it well and
showed a decrease in fecal calprotectin, a byproduct of neutrophil
breakdown in the gut, as well as a decrease in the number of
infiltrating neutrophils. These biomarker reductions are
evidence for the novel mode-of-action directed toward neutrophil
migration. Reduction in neutrophil influx did not translate
to improvement in signs and symptoms during this four week
study. Galapagos is performing subgroup analyses,
exploring additional indications, and discussing further
development of GLPG0974 with potential partners.
Cystic fibrosis programs In
addition to potentiator GLPG1837, Galapagos and its partner AbbVie
have discovered multiple series of correctors that show better
activity than VX-809 in pre-clinical tests in the f508del mutation,
which affects 87% of CF patients. Multiple
corrector-potentiator combinations are under development that
restore up to 65% of healthy (wild type) CFTR activity in
cells with the f508del mutation. GLPG1837 is expected to
enter the clinic by end 2014. A first corrector pre-clinical
candidate nomination is also expected this year.
Anti-infectives program
Galapagos has a fully proprietary narrow spectrum antibiotic with a
novel mode-of-action against Methicillin-resistant Staphylococcus
aureus, GLPG1492, which is expected to be dosed in first volunteers
(Phase 1) in the second half of 2014. Galapagos will
highlight pre-clinical data with GLPG1492 showing in vitro cidality
and in vivo efficacy, with broad coverage of all known MRSA
strains. Galapagos has discovered that the mode of action for
GLPG1492 can be utilized as a platform for addressing gram positive
and gram negative bacteria posing major public health threats,
including the ESKAPE pathogens.
Conference call and webcast presentation
Galapagos will conduct a conference call open to
the public today at 8:00 AM Eastern/14:00 Central European Time
(CET), which will also be webcast. To participate in the
conference call, please call one of the following numbers ten
minutes prior to commencement:
Confirmation Code: |
2952966 |
Conference call numbers Local -
Brussels, Belgium: |
+32 2 404 0660 |
Local - New York, USA: |
+1 646 254 3362 |
National free phone - USA: |
+1 877 280 2296 |
National free phone - Belgium: |
0800 58033 |
|
|
|
|
A question and answer session will follow the
presentation of the results. Go to www.glpg.com to
access the live audio webcast. The archived webcast will also
be available for replay shortly after the close of the call.
About Galapagos Galapagos (Euronext: GLPG; OTC:
GLPYY) is specialized in novel modes-of-action, with a large
pipeline comprising five Phase 2 studies (two led by GSK), one
Phase 1 study, five pre-clinical, and 20 discovery small-molecule
and antibody programs in cystic fibrosis, inflammation,
antibiotics, metabolic disease, and other indications. In the
field of inflammation, AbbVie and Galapagos signed a worldwide
license agreement whereby AbbVie will be responsible for further
development and commercialization of GLPG0634 after Phase
2B. 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 in Phase 2 in Crohn's disease. Galapagos has another
selective JAK1 inhibitor in Phase 2 in ulcerative colitis and
psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by
GlaxoSmithKline in 2012). GLPG0974 is the first
inhibitor of FFA2 to be evaluated clinically for the treatment of
IBD; this program has completed a Proof-of-Concept Phase 2
study. GLPG1205 is a first-in-class molecule that
targets inflammatory disorders and has completed Phase 1.
AbbVie and Galapagos signed an agreement in CF whereby they
work collaboratively to develop and commercialize oral drugs that
address two mutations in the CFTR gene, the G551D and F508del
mutation. Potentiator GLPG1837 is at the pre-clinical
candidate stage. The Galapagos Group, including
fee-for-service subsidiary Fidelta, has around 400 employees,
operating from its Mechelen, Belgium headquarters and facilities in
The Netherlands, France, and Croatia. Further information at:
www.glpg.com
CONTACT
For media and investor inquiries: Elizabeth
Goodwin, Head of Corporate Communications & Investor Relations
Tel: +31 6 2291 6240 ir@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 such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this
document. Galapagos expressly disclaims any obligation to update
any such forward-looking statements in this document to reflect any
change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is
based, unless required by law or regulation.
HUG#1793812
Aristocrat (PK) (USOTC:ASCC)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
Aristocrat (PK) (USOTC:ASCC)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024