Mechelen, Belgium; 4 April 2017; 7.30
CET -Galapagos NV (Euronext & NASDAQ: GLPG)
announces three new Phase 2 Proof-of-Concept studies investigating
filgotinib in Sjögren's syndrome, ankylosing spondylitis, and
psoriatic arthritis. The Sjögren's study is being led by filgotinib
collaboration partner Gilead Sciences, Inc.; the ankylosing
spondylitis and psoriatic arthritis studies by Galapagos.
"We are pleased with the rapid initiation of
these three new proof-of-concept studies with filgotinib," said Dr.
Walid Abi-Saab, Chief Medical Officer of Galapagos. "We look
forward to seeing the study results which will show whether
filgotinib can impact signs and symptoms of these three disease
areas."
Galapagos and Gilead entered into a global
collaboration for the development and commercialization of
filgotinib in inflammatory indications. These Phase 2 studies in
Sjögren's syndrome, ankylosing spondylitis, and psoriatic arthritis
are incremental to the ongoing FINCH Phase 3 program in rheumatoid
arthritis, the DIVERSITY Phase 3 study in Crohn's disease (also
small bowel and fistulizing Crohn's disease), and the SELECTION
Phase 2b/3 study in ulcerative colitis initiated 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
Filgotinib in Sjögren's syndromeThe Phase
2 study will be a multi-center, randomized, double-blind,
placebo-controlled study in adult patients with active Sjögren's
syndrome. Approximately 140 patients are planned to be randomized
in 60-80 centers globally to receive either filgotinib, placebo or
two other investigational regimens administered once daily for up
to 48 weeks. The primary endpoint will be the percentage of
patients on treatment fulfilling protocol-specified clinical
response criteria at week 12.
Sjögren's Syndrome is a systemic inflammatory
disease which can be felt throughout the body, often resulting in
chronic dryness of the eyes and mouth. Along with symptoms of
extensive dryness, other serious complications include profound
fatigue, chronic pain, major organ involvement, neuropathies and
lymphomas. The disease is estimated to affect up to 1% of the
population worldwide, and nine out of ten Sjögren's syndrome
patients are women. The average age of diagnosis is in the 40s,
although it can occur in all age groups and in both sexes.
Currently, there is no cure or disease-modifying drug approved for
Sjögren's syndrome. However, supportive treatments may improve
various symptoms. Prescription medicines for dry eyes and dry mouth
are available. Immunosuppressive medications are also used to treat
the serious internal organ manifestations.
Filgotinib in ankylosing spondylitis (AS)The TORTUGA
Phase 2 study will be 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 moderate
to severe active ankylosing spondylitis. Approximately 100 patients
are planned to be randomized in the study in a 1:1 ratio to receive
200 mg q.d. or placebo q.d. administered for 12 weeks. TORTUGA will
recruit in 8 European countries.
The primary goal of TORTUGA will be to evaluate
the effect of filgotinib compared to placebo on the signs and
symptoms of AS, as assessed by the Ankylosing Spondylitis Disease
Activity Score (ASDAS) at Week 12.
AS, a systemic, chronic, and progressive
inflammatory arthritis, is one of the most common rheumatic
diseases across the globe. AS primarily affects the spine and
sacroiliac (SI) joints and progresses into severe inflammation that
fuses the spine, leading to permanent painful stiffness of the
back. There are over 1 million prevalent cases of AS in the US,
Europe, and Japan.Currently, there is no known cure for AS, but
there are treatments and medications available to reduce symptoms
and manage pain. Recent studies show that the newer biologic
medications can potentially slow disease progression in some
people. Note that different people respond to different medications
with varying levels of effectiveness. Thus, it may take time to
find the most effective course of treatment.
Filgotinib in psoriatic arthritisThe EQUATOR Phase 2
study will be 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
moderately to severely active psoriatic arthritis. Approximately
124 patients are planned to be randomized in the study in a 1:1
ratio to receive 200 mg q.d. or placebo q.d. administered for 16
weeks. EQUATOR will recruit in 8 European countries.
Primary goal of EQUATOR will be to evaluate the
effect of filgotinib compared to placebo on the signs and symptoms
of psoriatic arthritis, as assessed by the American College of
Rheumatology 20% improvement score (ACR20) at Week 16. The study
will also explore the effects of filgotinib on the skin
manifestations (psoriasis) as well as other domains like fingers
(dactylitis), tendon insertions (tendinitis), spine involvement
(spondylitis) and nail involvement.
Psoriatic arthritis is an inflammatory form of
arthritis, affecting up to 30 percent of psoriasis patients.
Psoriatic arthritis can cause swelling, stiffness and pain in and
around the joints, cause nail changes and overall fatigue. Studies
show that delaying treatment for psoriatic arthritis as little as
six months can result in permanent joint damage. Early recognition,
diagnosis and treatment of psoriatic arthritis are critical to
relieve pain and inflammation and help prevent joint damage.
Despite the availability of a number of
treatment options, few current treatments effectively relieve the
enthesitis and symptoms in the joints and the skin. Sales of drugs
for psoriatic arthritis reached $4.5 billion in the US, EU, and
Japan in 2015 and are expected to grow to $12.6 billion by 2025,
driven by improved diagnosis.
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 a pipeline of 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
& Corporate Communications |
Director
Communications |
+1 781 460 1784
Paul van der HorstDirector IR & Business Development+31 6 53
725 199 |
+31 6 53 591
999communications@glpg.com |
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.
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