New Phase 2 studies with filgotinib in small bowel and fistulizing Crohn's disease
March 10 2017 - 1:31AM
Mechelen, Belgium; 10 March 2017 -
Galapagos NV (Euronext & NASDAQ: GLPG) announces two new
Phase 2 studies investigating filgotinib in small bowel
Crohn's disease as well as in fistulizing Crohn's disease. These
studies are being led by filgotinib collaboration partner Gilead
Sciences, Inc.
The first additional Crohn's disease Phase 2
study is a multi-center, randomized, double-blind,
placebo-controlled study to assess the safety and efficacy of the
investigational selective JAK1 inhibitor filgotinib in adult
patients with small bowel Crohn's disease. Approximately 100
patients in North America and Europe are planned to be randomized
in the study to receive one of two doses of filgotinib or placebo,
administered for 24 weeks. The primary objective will be to compare
filgotinib to placebo in establishing clinical remission, defined
as CDAI<150, in patients with small bowel Crohn's disease at
week 24.
The second Phase 2 study is a multi-center,
randomized, double-blind, placebo-controlled study to assess the
safety and efficacy of the selective JAK1 inhibitor filgotinib in
adult patients with perianal fistulizing Crohn's disease.
Approximately 75 patients are planned to be randomized in the study
to receive one of two doses of filgotinib or placebo administered
for 24 weeks. The primary objective is to evaluate the efficacy of
filgotinib, compared to placebo, in establishing a combined fistula
response at week 24.
Eligible patients who complete either study may
be able to continue in a long term extension study.
These new Phase 2 studies with filgotinib follow
the initiation of the DIVERSITY Phase 3 study in Crohn's disease.
Gilead further initiated the FINCH Phase 3 program in rheumatoid
arthritis and the SELECTION Phase 2b/3 study in ulcerative colitis
in 2016.
Filgotinib is an investigational drug and its efficacy and
safety have not been established.For information about the studies
with filgotinib: www.clinicaltrials.govFor more information about
filgotinib: www.glpg.com/filgotinib
About small bowel Crohn's disease (SBCD)Crohn's disease
causes chronic inflammation and erosion of the intestines. It can
affect different regions of GI tract including the stomach and
small and large intestines. While isolated SBCD is an uncommon
presentation of CD, involvement of some portion of the small bowel
(SB), particularly the ileum, is common. Precise estimates of SB
involvement vary in the literature, but generally, some involvement
occurs in up to 70% of patients, with isolated SB disease reported
in up to a third of patients {Hall 2015}. Patients with SBCD
experience cramps, diarrhea, abdominal discomfort (sometimes
severe) and fistulae.[1] While there is no therapy approved for
SBCD specifically, current treatment involves anti-tumor necrosis
factor antibodies and other biologics.
About perianal fistulizing Crohn's diseaseFistulae are
inflammatory tracts that most often occur between the distal colon
and the perianal region. Fistulae are one of the most severe
sequelae of luminal CD and the lifetime risk of occurrence is close
to 50% of those with active CD. Fistulizing CD may also cause
painful abscesses in the abdomen. In acute fistulizing perianal CD,
the lesions represent manifestations of severe disease activity and
are concomitantly managed with medications that treat underlying
luminal disease (e.g., anti-TNF antibodies). Fistulae may progress
to destruction of the sphincter apparatus necessitating proctectomy
after years of continual inflammation and tissue erosion. Despite
use of available therapies, long term or durable remission rates
for fistulizing CD are still low at approximately 20%.
About GalapagosGalapagos (Euronext & NASDAQ: GLPG) is
a clinical-stage biotechnology company specialized in the discovery
and development of small molecule medicines with novel modes of
action. Our pipeline comprises Phase 3, Phase 2, Phase 1,
pre-clinical, and discovery programs in cystic fibrosis,
inflammation, fibrosis, osteoarthritis and other indications. We
have discovered and developed filgotinib: in collaboration with
Gilead we aim to bring this JAK1-selective inhibitor for
inflammatory indications to patients all over the world. Galapagos
is focused on the development and commercialization of novel
medicines that will improve people's lives. The Galapagos group,
including fee-for-service subsidiary Fidelta, has approximately 510
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contacts
Investors: |
Media: |
Elizabeth Goodwin |
Evelyn
Fox |
VP IR
& CorporateCommunications+1 781 460 1784 |
Director
Communications+31 6 53 591 999communications@glpg.com |
Paul van der HorstDirector IR & BusinessDevelopment+31 6 53 725
199 |
|
ir@glpg.com |
|
Forward-looking statementsThis release may contain
forward-looking statements, including statements regarding
Galapagos' strategic ambitions, the anticipated timing of clinical
studies with filgotinib and the progression and results of such
studies. Galapagos cautions the reader that forward-looking
statements are not guarantees of future performance.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos'
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are the inherent uncertainties associated
with competitive developments, clinical trial and product
development activities and regulatory approval requirements
(including that data from the ongoing and planned clinical research
programs may not support registration or further development of
filgotinib due to safety, efficacy or other reasons), Galapagos'
reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), and estimating the
commercial potential of Galapagos' product candidates. A further
list and description of these risks, uncertainties and other risks
can be found in Galapagos' Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos' most recent annual
report on form 20-F filed with the SEC and subsequent filings and
reports filed by Galapagos with the SEC. 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 or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
[1] From
http://www.healthline.com/health/crohns-disease/types#TheFiveTypes2
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