-- EQUATOR Achieves Primary Endpoint of
ACR20 Response at Week 16 --
-- Galapagos to Receive $15 Million Payment
from Gilead for Progression into Phase 3 of the Phase 2b/3
SELECTION Study of Filgotinib in Ulcerative Colitis --
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext
& NASDAQ: GLPG) announced that the randomized,
placebo-controlled Phase 2 EQUATOR study of filgotinib, an
investigational, selective JAK1 inhibitor, in 131 adults with
moderate to severe psoriatic arthritis, achieved its primary
endpoint of improvement in the signs and symptoms of psoriatic
arthritis at Week 16, as assessed by the American College of
Rheumatology 20 percent improvement score (ACR20). There was an
ACR20 response of 80 percent for filgotinib versus 33 percent for
placebo (p<0.001). The ACR50 and ACR70 responses at Week 16 were
also significantly higher for filgotinib versus placebo (ACR50: 48
percent for filgotinib versus 15 percent, p<0.001; ACR70: 23
percent versus 6 percent, p<0.01).
Filgotinib was generally well-tolerated in the EQUATOR trial,
with no new safety signals observed and similar laboratory changes
compared to those reported in previous trials with filgotinib in
rheumatoid arthritis patients. The adverse event rate was similar
in both groups with mostly mild or moderate events reported. There
was one serious infection in the filgotinib group, a patient who
experienced pneumonia with a fatal outcome. One other patient
receiving filgotinib developed herpes zoster. There were no cases
of opportunistic infection, tuberculosis, thromboembolism, or
malignancy.
“The data from the EQUATOR study are very impressive and
indicate that filgotinib has the potential to have a significant
effect on signs and symptoms of psoriatic arthritis, a condition
where there is still a high unmet medical need,” said Dr. Philip
Mease, Director of Rheumatology Research, Swedish-Providence-St.
Joseph Health Systems and Clinical Professor, University of
Washington, Seattle, WA.
“We are pleased to report that filgotinib remains consistent in
terms of activity and tolerability, now also in psoriatic
arthritis,” said Dr. Walid Abi-Saab, Chief Medical Officer at
Galapagos.
Detailed results from the EQUATOR trial will be submitted for
presentation at a future scientific conference.
Separately, Gilead and Galapagos also announced that an
independent Data Monitoring Committee (DMC) conducted a planned
interim futility analysis of the filgotinib Phase 2b/3 ulcerative
colitis study, SELECTION, after 350 patients completed the
induction period in the Phase 2b portion of the study. The DMC
recommended that the study proceed into Phase 3 as planned at both
the 100 mg and 200 mg once daily dose level in biologic-experienced
and biologic-naïve patients.
Galapagos is to receive a $15 million payment from Gilead for
this progression from Phase 2 to Phase 3 in the SELECTION
trial.
“We continue to see great potential with filgotinib to treat a
range of inflammatory diseases,” said John McHutchison, MD, Chief
Scientific Officer, Head of Research and Development, Gilead. “As
such, we are pleased with the continued progress of the development
programs, including the EQUATOR results and advancing the SELECTION
study into Phase 3.”
Filgotinib is investigational and 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 the selective JAK1
inhibitor filgotinib in adult patients with moderately to severely
active psoriatic arthritis. 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
filgotinib 200 mg or placebo once-daily administered for 16 weeks;
85 percent of the patients were naïve to TNF treatment.
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 ACR20 at Week 16. Secondary
objectives included ACR50/70 and minimum disease activity (MDA) as
well as the effects of filgotinib on psoriasis, dactylitis (whole
finger inflammation) and enthesitis (inflammation of the
tendons).
About Psoriatic
Arthritis
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 enthesitis and symptoms in the
joints and the skin.
About the SELECTION Phase 3
Trial
Initiated by Gilead in late 2016, the SELECTION Phase 2b/3 trial
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 moderately to severely
active ulcerative colitis. A total of 1,300 patients are targeted
to be randomized to receive filgotinib 100 mg, 200 mg, or placebo
once-daily administered for 58 weeks. The primary objective of
SELECTION is to evaluate the efficacy of filgotinib as compared to
placebo in establishing EBS (endoscopy, bleeding, stool) remission
at Week 10.
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 EQUATOR trial in psoriatic arthritis is
one of several Phase 2 trials in inflammatory diseases that were
initiated in 2017 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 2b/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 640 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 psoriatic
arthritis, 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 March 31, 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.comorPaul van der Horst, +31 71 750
6707Director IR & Business
Developmentir@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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