Galapagos announces three new Phase 2 Proof-of-Concept studies with filgotinib
(Thomson Reuters ONE) -
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.gov
For more information about filgotinib: www.glpg.com/filgotinib
Filgotinib in Sjögren's syndrome
The 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 arthritis
The 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 Galapagos
Galapagos (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 +31 6 53 591 999
communications(at)glpg.com
Paul van der Horst
Director IR & Business Development
+31 6 53 725 199
ir(at)glpg.com
Forward-Looking Statements
This 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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Source: Galapagos NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 04.04.2017 - 07:31 Uhr
Sprache: Deutsch
News-ID 534159
Anzahl Zeichen: 11744
contact information:
Town:
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Kategorie:
Business News
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