First clinical centers opened for Phase 2 Crohn's study with GLPG0634
January 29 2014 - 9:35AM
- First selective JAK1 inhibitor to enter Phase 2 in
Crohn's disease
- 180 patients to be enrolled for 20 weeks of
treatment
- Topline data expected in Q2 2015
- Galapagos eligible for $50 M success fee from AbbVie
upon study completion
Galapagos NV (Euronext: GLPG) announced today that the first
clinical centers have been opened for enrolment in the Phase 2
clinical study in Crohn's disease with GLPG0634, a selective JAK1
inhibitor. The Phase 2 study will evaluate the efficacy and safety
of GLPG0634 during 20 weeks of treatment in 180 patients with
active Crohn's disease.
GLPG0634 is the first selective JAK1 inhibitor
in development for Crohn's disease. The innovative design of the
Phase 2 study with GLPG0634 will evaluate induction of disease
remission and explore early maintenance of its beneficial effects,
potentially enabling a rapid entry into Phase 3 studies.
Galapagos will fund and conduct the Phase 2 study in Crohn's
disease, recruiting patients in approximately 49 clinical centers
throughout Western and Eastern Europe. Upon successful
completion of the Crohn's study, AbbVie will pay Galapagos $50
million. Galapagos expects to read out topline results in Q2
2015. Full details of the study design can be found on
www.clinicaltrials.gov.
"We are very pleased to announce the start of
the Crohn's study with GLPG0634, the first selective JAK1 inhibitor
in Phase 2 in Crohn's disease," said Dr Piet Wigerinck, Chief
Scientific Officer of Galapagos. "Galapagos' pipeline has
really matured. Patient studies in six different indications
should deliver readouts within the next year or two, making for a
truly data-rich period for Galapagos going forward."
The Phase 2 study in Crohn's disease will be
performed in parallel with the Phase 2B program for GLPG0634 in
rheumatoid arthritis (RA), which includes two dose-finding studies
of 24 weeks of treatment in 875 moderate to severe RA patients
refractory to methotrexate, and an open label extension
study. Galapagos expects to report 12-week topline data from
the Phase 2B RA program in Q4 2014, and 24-week data in Q1 2015.
AbbVie has the exclusive right to license GLPG0634 upon
completion of the Phase 2B RA studies.
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 pay $200 million, license the
program, and will assume sole responsibility for Phase 3 clinical
development and global manufacturing. Galapagos will then be
eligible to receive additional downstream milestones, plus tiered
double-digit royalties on global commercial sales.
About Crohn's disease
Crohn's disease is a type of inflammatory bowel
disease in which the well-controlled balance of the intestinal
immune system is disturbed. The disease causes ulcerations of
the small and large intestines in particular, but may affect any
part of the digestive system from mouth to anus. The cause of
the disease is unknown, with onset usually between the ages of 15
and 35. Patients suffer from abdominal pain, diarrhea (often
bloody), vomiting, fever, and weight loss. There is no cure
for Crohn's disease; treatment options today are restricted to
controlling symptoms, maintaining remission, and preventing relapse
by the use of drugs that suppress the inflammation or the immune
system, antibiotics, and eventually surgical removal of the
inflamed bowels. Driven by new therapies in development,
Decision Resources estimates that the market for Crohn's disease
treatment will grow from $3.8 Billion in 2011 to $5.6 Billion in
2021.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel
modes-of-action, with a large pipeline comprising of six Phase 2
studies (three 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. AbbVie and Galapagos signed an agreement in CF where
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. 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 about to enter Phase 2 studies in
Crohn's disease. Galapagos has another selective JAK1
inhibitor in Phase 2 in ulcerative colitis, psoriasis, and lupus,
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 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. The Galapagos Group, including fee-for-service
companies BioFocus, Argenta and Fidelta, has around 800 employees
and operates facilities in five countries, with global headquarters
in Mechelen, Belgium. Further information at:
www.glpg.com
Contact
Galapagos NV Elizabeth Goodwin, Head of
Corporate Communications & Investor Relations Tel: +31 6 2291
6240 ir@glpg.com
Galapagos forward-looking statements
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.
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