GSK2586184 met primary endpoint in Phase 2a psoriasis study
17 Avril 2014 - 7:03AM
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%
GSK2586184). A final analysis of the data from study
JAK116679 will be submitted for presentation at an upcoming
scientific congress and/or a peer-reviewed publication. 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 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.
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. GLPG0974 is 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. 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. Galapagos has 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 RelationsTel: +31 6 2291
6240ir@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
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