Company Website:
http://www.gilead.com
FOSTER CITY, Calif. & MECHELEN, Belgium -- (Business Wire)
Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV (Euronext &
NASDAQ:GLPG) today announced that the randomized, placebo-controlled
Phase 2 TORTUGA study of filgotinib, an investigational, selective JAK1
inhibitor, achieved its primary efficacy endpoint in adults with
moderately to severely active ankylosing spondylitis (AS). In the study,
patients treated with filgotinib achieved significantly greater
improvements in AS Disease Activity Score (ASDAS), the primary endpoint,
at Week 12, with a mean change from baseline of -1.5 versus -0.6 for
those treated with placebo (p<0.0001). More patients receiving
filgotinib also achieved an ASAS20 response compared to those treated
with placebo (76 percent versus 40 percent, p<0.0001).
“People with ankylosing spondylitis face serious pain and disability,
and, too often, their disease does not respond adequately to existing
therapies,” said John McHutchison, MD, Chief Scientific Officer, Head of
Research and Development, Gilead. “These data are encouraging,
suggesting filgotinib has the potential to play an important role in
addressing this medical need.”
“We are excited to see that filgotinib showed strong activity across a
wide range of parameters relevant for ankylosing spondylitis and was
well tolerated in TORTUGA, which reinforces previous findings about the
activity and tolerability profile of filgotinib in multiple inflammatory
conditions,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.
Adverse events were generally mild or moderate in severity and were
reported in an equal proportion of patients in the filgotinib and
placebo groups. Laboratory changes were consistent with those previously
reported for filgotinib, and no new safety signals were observed in the
study. There was one treatment-emergent serious adverse event reported
for a patient receiving filgotinib who experienced pneumonia and
recovered after hospital-based antibiotic treatment. One patient
randomized to filgotinib, with an inherited risk for thrombosis,
experienced a non-serious deep venous thrombosis after completing the
course of study drug. No deaths, malignancies, hepatic events,
opportunistic infections or cases of Herpes zoster were observed in the
study.
Detailed results from the TORTUGA trial will be submitted for
presentation at a future scientific conference.
Filgotinib is investigational and not approved anywhere globally. Its
efficacy and safety have not been established. For information about the
clinical trials with filgotinib: www.clinicaltrials.gov.
About the TORTUGA Study
TORTUGA was a multi-center, randomized, double-blind,
placebo-controlled, Phase 2 study to assess the safety and efficacy of
filgotinib in adult patients with moderately to severely active AS. The
trial was conducted in Belgium, Bulgaria, Czech Republic, Estonia,
Poland, Spain and Ukraine. In total, 116 patients were randomized in a
1:1 ratio to receive filgotinib 200 mg or placebo once daily for 12
weeks.
The primary objective of TORTUGA was to evaluate the effect of
filgotinib compared to placebo on the signs and symptoms of AS, as
assessed at Week 12 by ASDAS (a standard composite index for assessing
the disease, which incorporates five disease activity variables).
About Ankylosing Spondylitis
AS is a systemic, chronic, and progressive seronegative
spondyloarthritis that classically affects the spine and sacroiliac (SI)
joints and may progress to spinal fusion, leading to permanent
disability. Currently, there is no known cure for AS, but there are
treatments and medications available to reduce signs and symptoms and
manage pain.
About the Galapagos – Gilead Collaboration
Galapagos and Gilead entered into a global collaboration for the
development and commercialization of filgotinib in inflammatory
indications. The Phase 2 TORTUGA trial in ankylosing spondylitis is one
of several Phase 2 trials in inflammatory diseases in addition to the
ongoing FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY
Phase 3 trial in Crohn’s disease (also small bowel and fistulizing
Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION trial in
ulcerative colitis.
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. Galapagos’ pipeline comprises
Phase 3 through to discovery programs in cystic fibrosis, inflammation,
fibrosis, osteoarthritis and other indications. Our target discovery
platform has delivered three novel mechanisms showing promising patient
results in, respectively, inflammatory diseases, idiopathic pulmonary
fibrosis and atopic dermatitis. 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 675 employees, operating from its Mechelen,
Belgium headquarters and facilities in the Netherlands, France,
Switzerland, the US and Croatia. More information at www.glpg.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com.
Galapagos Forward-Looking Statements
This release may contain forward-looking statements with respect to
Galapagos, including statements regarding Galapagos’ strategic
ambitions, the mechanism of action and potential safety and efficacy of
filgotinib, 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.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
parties’ ability to complete the clinical trial programs evaluating
filgotinib for the treatment of ankylosing spondylitis, ulcerative
colitis and other inflammatory diseases in the currently anticipated
timelines, or at all. In addition, there is the possibility of
unfavorable results from additional clinical trials involving
filgotinib. Further, it is possible that the parties may make a
strategic decision to discontinue development of filgotinib, and as a
result, filgotinib may never be successfully commercialized. All
statements other than statements of historical fact are statements that
could be deemed forward-looking statements. These risks, uncertainties
and other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These and
other risks are described in detail in Gilead’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2018, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements are
based on information currently available to Gilead, and Gilead assumes
no obligation to update any such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180905006051/en/
Contacts:
Galapagos Contacts
Investors:
Elizabeth
Goodwin, +1-781-460-1784
VP IR & Corporate Communications
ir@glpg.com
Paul
van der Horst, +31 71 750 6707
Director IR & Business Development
ir@glpg.com
or
Media:
Evelyn
Fox, +31 6 53 591 999
Director Communications
communications@glpg.com
or
Gilead
Contacts
Investors:
Sung Lee, +1-650-524-7792
or
Media:
Nathan
Kaiser, +1-650-522-1853
Source: Gilead Sciences, Inc.
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