-- Phase 3 FINCH 1 and FINCH 3 Data of
Filgotinib in Rheumatoid Arthritis to Be Featured in Opening
Plenary and Late Breaker Sessions --
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext
& NASDAQ: GLPG) today announced that data on filgotinib, an
investigational, oral, selective JAK1 inhibitor, will be presented
at the Annual European Congress of Rheumatology (EULAR 2019) in
Madrid, Spain, on June 12-15, 2019. Among the abstracts to be
presented are 24 week interim results from the ongoing FINCH 1 and
FINCH 3 Phase 3 studies evaluating filgotinib in adults with
rheumatoid arthritis.
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“These data reinforce our belief that filgotinib has the
potential to make a meaningful difference for patients with
rheumatoid arthritis, both early and also late in the course of
treatment when other treatments have failed,” said John
McHutchison, AO, MD, Chief Scientific Officer, Head of Research and
Development, Gilead Sciences. “The FINCH results reflect the
growing strength and breadth of Gilead’s inflammation pipeline and
our commitment to improving the outlook for patients living with
inflammatory diseases – both with filgotinib and our other
investigational compounds.”
“This meeting marks our first opportunity to present the results
from the FINCH 1 and 3 filgotinib trials in rheumatoid arthritis,”
said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos. “These
results show the potential of filgotinib in helping to address the
unmet need for people living with this debilitating disease.”
Phase 3 Trials of Filgotinib in
Rheumatoid Arthritis
Detailed 24 week interim results from the Phase 3 FINCH 1 and 3
clinical trials will both be presented for the first time in oral
sessions at the conference. Top-line data from these studies were
announced earlier this year. Findings from FINCH 1 will be
presented in the opening plenary session, while FINCH 3 results
will be presented in the late-breaking abstract session.
- Efficacy and Safety of Filgotinib for
Patients with Rheumatoid Arthritis with Inadequate Response to
Methotrexate: FINCH1 Primary Outcome Results (oral #LB0001 4:25pm
CET, 12 June, Hall 6)
- Efficacy and Safety of Filgotinib for
Patients with Rheumatoid Arthritis Naïve to Methotrexate Therapy:
FINCH3 Primary Outcome Results (oral #LB0003 8:00am CET, 15 June,
Hall 7B)
FINCH 1 is an ongoing, randomized, double-blind, placebo- and
active-controlled Phase 3 study evaluating filgotinib versus
adalimumab or placebo in adults with moderately-to-severely active
rheumatoid arthritis on a stable background dose of methotrexate
but with a prior inadequate response to methotrexate. The study
achieved its primary endpoint at both 100 mg and 200 mg doses of
filgotinib, in the proportion of patients achieving an American
College of Rheumatology (ACR) 20 percent response (ACR20) compared
with placebo at Week 12.
The proportion of patients achieving an ACR 50 percent response
(ACR50) or ACR 70 percent response (ACR70) was significantly
greater for filgotinib compared with placebo at Week 12, for both
doses. The study also achieved key secondary endpoints, including
significant inhibition of radiographic progression with both doses
of filgotinib versus placebo.
FINCH 3 is an ongoing, randomized, double-blind,
active-controlled Phase 3 study of filgotinib in adults with
moderately-to-severely active rheumatoid arthritis. The trial
evaluated filgotinib in combination with methotrexate and as
monotherapy in methotrexate-naïve patients. The study achieved its
primary endpoint, with a significantly higher proportion of
patients reaching ACR20 in the filgotinib plus methotrexate groups
compared with patients receiving methotrexate alone. Additionally,
both doses of filgotinib demonstrated significantly higher ACR 50
and ACR 70 responses than methotrexate alone.
In both trials, filgotinib demonstrated a safety profile
consistent with previously reported results.
Additional abstracts accepted for presentation at the meeting
include:
- Filgotinib in Patients with Rheumatoid
Arthritis and Prior Inadequate Response or Intolerance to Biologic
DMARDs (bDMARD-IR) by Geographic Region and Race (poster
#THU0173)
- Selective Inhibition of Janus Kinase 1
(JAK1) by Filgotinib Modulates the Disease-associated Whole Blood
Transcriptional Profile of Patients with Active Rheumatoid
Arthritis (poster #THU0194)
- Safety and Efficacy of Filgotinib in
Active Rheumatoid Arthritis by Prior Biologic DMARD Exposure in
Patients with Prior Inadequate Response or Intolerance to Biologic
DMARDs (bDMARD-IR) (poster #FRI0092)
- Filgotinib, a Selective Janus Kinase 1
(JAK1) Inhibitor, Modulates Disease-associated Cytokines in
Patients with Active Rheumatoid Arthritis (poster #FRI0113)
- Safety and Efficacy of Filgotinib in
Patients Aged 65 Years and Older: Results from a Phase 3 Study in
Patients with Active Rheumatoid Arthritis and Prior Inadequate
Response or Intolerance to Biologic DMARDs (bDMARD-IR) (poster
#FRI0154)
Additional Data on Filgotinib in
Inflammatory Disease Management
In addition to the FINCH studies, Gilead and Galapagos will
present results from EQUATOR, a Phase 2, placebo-controlled,
double-blind study of filgotinib among patients with active
psoriatic arthritis; additional clinical data on filgotinib in
individuals with hepatic impairment; and preclinical data
characterizing filgotinib among JAK inhibitors and in combination
with an ASK1 inhibitor.
- Efficacy of Filgotinib vs. Placebo in
Active Psoriatic Arthritis: Patient-Level Data from EQUATOR, a
Randomized, Phase 2 Study (oral #OP0109)
- Filgotinib Treatment Provides Rapid and
Sustained Reduction of Inflammatory Biomarkers in Moderate to
Severe Psoriatic Arthritis (PsA) Patients (poster #THU0031)
- PsAID9 in Patients with Active
Psoriatic Arthritis Treated with Filgotinib vs Placebo: Results
from EQUATOR, a Randomized, Phase 2 Study (poster #SAT0367)
- Effect of filgotinib on
Patient-reported Outcomes in Active Psoriatic Arthritis: Results
from EQUATOR, a Randomized, Phase 2 Study (poster #SAT0373)
- In Vitro Mechanistic Studies
Demonstrate Filgotinib Activity that Has Potential Implications for
Differentiation among JAK Inhibitors (poster #THU0017)
- Pharmacokinetics and Short-Term Safety
of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Subjects
with Moderate Hepatic Impairment: a Phase 1, Open-label, Single-arm
Study (poster #THU0117)
- Targeting Activated ASK1 in Synovial
Fibroblasts in Combination with Jak1 Inhibition Enhances Efficacy
in Rat CIA (poster #THU0014)
Filgotinib is an investigational agent and is not approved by
the U.S. Food and Drug Administration or any other regulatory
authority. Its efficacy and safety have not been established.
About the Galapagos – Gilead
Collaboration
Galapagos and Gilead entered into a global collaboration for the
development and commercialization of filgotinib in inflammatory
indications. The FINCH studies are among several clinical trials of
filgotinib in inflammatory diseases, including 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) discovers and develops
small molecule medicines with novel modes of action, three of which
show promising patient results and are currently in late-stage
development in multiple diseases. Our pipeline comprises Phase 3
through to discovery programs in inflammation, fibrosis,
osteoarthritis and other indications. Our ambition is to become a
leading global biopharmaceutical company focused on the discovery,
development and commercialization of innovative medicines. 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
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. 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, 2019, 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 GoodwinVP
IR+1-781-460-1784
Sofie Van GijselDirector IR+32 485 19 14 15ir@glpg.com
Media:Carmen VroonenSenior Director Communications+32 473
824 874
Evelyn FoxDirector Communications+31 6 53 591
999communications@glpg.com
Gilead
ContactsInvestors:Sung Lee+1 650-524-7792
Media:Arran Attridge+1 650-425-8975
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