-- Phase 2 EQUATOR Data Demonstrating
Efficacy in Psoriatic Arthritis Also Presented in a Plenary Session
at 2018 ACR/ARHP Annual Meeting --
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& NASDAQ: GLPG) today announced that detailed results from two
clinical trials evaluating filgotinib, an investigational,
selective JAK1 inhibitor, for the treatment of psoriatic arthritis
and ankylosing spondylitis were both published in The Lancet. The
publication of the Phase 2 EQUATOR data also coincides with a
plenary session presentation at the 2018 American College of
Rheumatology/Association of Rheumatology Health Professionals
(ACR/ARHP) Annual Meeting.
“The results of the EQUATOR and TORTUGA studies demonstrate that
filgotinib improved the signs and symptoms of patients with
psoriatic arthritis whose disease had not responded to prior
therapies and independently, for those with ankylosing
spondylitis,” said John McHutchison, AO, MD, Chief Scientific
Officer and Head of Research and Development, Gilead Sciences.
“These findings represent an important step forward in our efforts
to improve outcomes for people living with these inflammatory
diseases.”
“We are pleased that filgotinib demonstrates a consistent safety
and efficacy profile across multiple inflammatory conditions,
including psoriatic arthritis and ankylosing spondylitis,” said Dr.
Walid Abi-Saab, Chief Medical Officer at Galapagos. “We look
forward to sharing additional updates as we continue to develop
this compound for patients in need of additional therapy
options.”
Phase 2 EQUATOR Study in Psoriatic Arthritis [ACR/ARHP
Abstract #1821]
Data from EQUATOR, a placebo-controlled trial of 131 adults with
moderately to severely active psoriatic arthritis who had an
inadequate response or were intolerant to at least one conventional
disease-modifying anti-rheumatic drug (cDMARD), demonstrated the
efficacy of filgotinib in this patient population. The study
achieved its primary endpoint at Week 16, with 80 percent of
patients on filgotinib 200mg once-daily achieving ACR20, compared
with 33 percent on placebo (p<0.001). ACR50 and ACR70 responses
at Week 16 were also significantly higher for filgotinib compared
with placebo (ACR50: 48 percent for filgotinib vs 15 percent for
placebo, p<0.001; ACR70: 23 percent vs 6 percent, p<0.01).
These data were previously announced in May 2018.
The study also found greater improvement in disease signs and
symptoms for patients receiving filgotinib 200mg once-daily
compared with placebo at Week 16, as measured by Minimal Disease
Activity (MDA) (23 percent vs 9 percent, p<0.05) and the
Psoriasis Area and Severity Index 75 percent improvement from
baseline (PASI75) (45 percent vs 15 percent, p<0.01). The data
showed greater improvement from baseline in the Health Assessment
Questionnaire Disability Index (HAQ-DI) for those receiving
filgotinib compared with placebo (-0.57 vs -0.28, p<0.001).
Safety-related outcomes were similar between the filgotinib and
placebo arms of the study, including rates of treatment-emergent
adverse events (57 percent and 59 percent, respectively) and
infections and infestations (22 percent and 21 percent). Two
serious treatment-emergent adverse events were reported: one hip
fracture in the placebo group and one case of fatal pneumonia in
the filgotinib treatment group, which was the only serious
infection and the only death in the study. No deep venous
thrombosis, pulmonary embolism, malignancies, gastrointestinal
perforations, opportunistic infections/active tuberculosis or cases
of Herpes zoster were reported.
“Effective treatment for psoriatic arthritis is critical for
relieving pain and inflammation and helping to prevent joint
damage. Unfortunately, not all patients respond to currently
available therapies,” said Philip J. Mease, MD, Director of
Rheumatology Research, Swedish-Providence-St. Joseph Health Systems
and Clinical Professor, University of Washington. “These results
indicate that filgotinib has the potential to address the needs of
individuals who require additional treatment options.”
Phase 2 TORTUGA Study in Ankylosing Spondylitis
In the Phase 2 TORTUGA study, adults with moderately to severely
active ankylosing spondylitis who were treated with filgotinib
200mg once-daily achieved significantly greater improvements in AS
Disease Activity Score (ASDAS), the primary endpoint, at Week 12.
The mean change from baseline in ASDAS was -1.5 for patients
treated with filgotinib versus -0.6 for those treated with placebo
(p<0.0001). ASAS20 and ASAS40 responses at Week 12 were also
significantly higher for filgotinib compared with placebo (ASAS20:
76 percent for filgotinib vs 40 percent for placebo, p<0.0001;
ASAS40: 38 percent vs 19 percent, p<0.05).
Adverse events were generally mild or moderate in severity and
were reported in an equal proportion of patients in the filgotinib
and placebo groups (31 percent). 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 of pneumonia reported for
a patient receiving filgotinib who recovered after hospital-based
antibiotic treatment. One patient with an inherited risk for
thrombosis who was randomized to filgotinib experienced a
non-serious deep venous thrombosis after completing the course of
study drug. No deaths, malignancies, hepatic events,
gastrointestinal perforations, opportunistic infections/active
tuberculosis, or cases of Herpes zoster were reported.
Full results of both studies are now available in The
Lancet:
Efficacy and safety of filgotinib, a selective Janus kinase 1
inhibitor, in patients with active psoriatic arthritis (EQUATOR):
results from a randomised, placebo-controlled, phase 2 trial:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32483-8/fulltext
Efficacy and safety of filgotinib, a selective Janus kinase 1
inhibitor, in patients with active ankylosing spondylitis
(TORTUGA): results from a randomised, placebo-controlled, phase 2
trial:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32463-2/fulltext
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 EQUATOR Trial
Initiated by Galapagos in April 2017, the EQUATOR Phase 2 trial
was a multi-center, randomized, double-blind, placebo-controlled
trial to assess the safety and efficacy of filgotinib in adult
patients with moderately to severely active psoriatic arthritis who
had an inadequate response or were intolerant to conventional
disease-modifying anti-rheumatic drugs (cDMARDs). EQUATOR was
conducted in Ukraine, Poland, Estonia, Bulgaria, Spain, Czech
Republic and Belgium. In total, 131 patients were randomized in a
1:1 ratio to receive once-daily oral filgotinib 200mg or placebo
for 16 weeks; 85 percent of the patients were naïve to anti-TNF
treatments.
The primary objective of EQUATOR was to evaluate the effect of
filgotinib compared to placebo on the signs and symptoms of
psoriatic arthritis, as assessed by the proportion of patients
achieving ACR20 at Week 16. Secondary objectives included the
proportion of patients achieving ACR50/70 and MDA as well as the
effects of filgotinib on psoriasis, dactylitis (whole finger
inflammation) and enthesitis (inflammation of the tendons).
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 the Galapagos – Gilead
Collaboration
Galapagos and Gilead entered into a global collaboration for the
development and commercialization of filgotinib in inflammatory
indications. Filgotinib is being investigated in several clinical
trials in inflammatory diseases, including the Phase 3 trials in
rheumatoid arthritis FINCH 1, 2 and 3, the EQUATOR Phase 2 program
in psoriatic arthritis, the TORTUGA study in ankylosing
spondylitis, 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
inflammation, fibrosis, cystic 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
Statement
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
Statement
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 possibility of unfavorable results from ongoing and
additional clinical trials involving filgotinib and the possibility
that we are unable to complete one or more of such trials on the
currently anticipated timelines. 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.
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Galapagos
ContactsInvestors:Elizabeth Goodwin,
+1-781-460-1784VP IR & Corporate Communicationsir@glpg.comSofie
Van Gijsel, +32 485 191415Director
IRir@glpg.comorMedia:Evelyn Fox, +31 6 53 591 999Director
Communicationscommunications@glpg.comorGilead ContactsInvestors:Sung Lee,
+1 650-524-7792orMedia:Nathan Kaiser, +1 650-522-1853
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