Du är här


Galapagos NV: GSK2586184 met primary endpoint in Phase 2a psoriasis study

Mechelen, Belgium; 17 April 2014 - Galapagos NV (Euronext: GLPG) announced
today that GSK provided Galapagos with the following information:

"Study JAK116679 was a phase 2a multi-centre, randomised, double-blind,
placebo-controlled, dose ranging study (100mg bid, 200mg bid, 400mg bid) that
evaluated the safety and efficacy of GSK2586184 compared with placebo in 66
patients with chronic plaque psoriasis
. Preliminary results showed that a significantly higher proportion of
patients treated with GSK2586184 at the 400mg bid dose met the primary
endpoint compared to placebo. The primary endpoint was defined as
achieving>=75% improvement from baseline in Psoriasis Area Severity Index
(PASI75) score at Week 12. PASI75 for patients randomised to placebo was in
the range expected.

During the treatment period the most common adverse events occurring with a
frequency of more than 20% on either placebo or pooled GSK2586184 were
headache (36% placebo, 27% GSK2586184) and nasopharyngitis (21% placebo, 29%
A final analysis of the data from study JAK116679 will be submitted for
presentation at an upcoming scientific congress and/or a peer-reviewed
GSK remains responsible for the study and intends to review the complete data
from all GSK2586184 studies before determining next steps.

"We at Galapagos are pleased to hear that GSK2586184 met the primary endpoint
in GSK's psoriasis study. This is the second selective JAK1 inhibitor and
candidate drug based on Galapagos' novel target approach to show efficacy in
patients. The next patient readout from our pipeline is expected in June
2014: our Phase 2 Proof of Concept study with GLPG0974, a fully proprietary
and novel mode of action in ulcerative colitis," said Dr Piet Wigerinck,
Chief Scientific Officer of Galapagos.

GSK2586184 is a selective JAK1 inhibitor which was discovered and developed
within Galapagos' inflammation alliance with GSK. GSK in-licensed the
molecule in February 2012, gaining worldwide rights to further development
and commercialization. Galapagos is eligible, without further financial
investment from Galapagos, to receive from GSK up to €34M in additional
milestones, plus up to double-digit royalties on global commercial sales of
all therapeutic indications of GSK2586184.

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, six 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 ofGLPG0634after 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. Selective JAK1
inhibitor GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in
2012) met the primary endpoint in a Phase 2 study in psoriasis. An
exploratory Phase 1/2 study in ulcerative colitis is currently on hold.
GLPG0974is the first inhibitor of FFA2 to be evaluated clinically for the
treatment of IBD; this program is currently in a Proof-of-Concept Phase 2
study. GLPG1205is 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. Galapagos has 400 employees, operating from its Mechelen,
Belgium headquarters and facilities in The Netherlands, France, and Croatia.
Further information at:www.glpg.com


For media and investor inquiries:
Elizabeth Goodwin, Head of Corporate Communications&Investor Relations
Tel: +31 6 2291 6240

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


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Galapagos NV via Globenewswire


Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.